MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other,user facili report with the FDA on 2018-03-23 for BARD? INTRA-ABDOMINAL PRESSURE MONITORING DEVICE IAP001 manufactured by C.r. Bard, Inc. (covington) -1018233.
[103321391]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[103321392]
It was reported that it was difficult to get the air bubbles out of the tubing. The complainant reportedly used about 500cc of saline to clear the air bubbles out of the tube. The complainant alleged an accurate reading of the patient's intake/output could not be obtained due to the large volume of saline used to get the air bubbles out. The complainant also reported that it took roughly 30-45 minutes for the set up. Per additional information received on (b)(6) 2018, the patient had developed compartment syndrome, and the surgeon wanted to obtain an intra-abdominal pressure before performing emergency surgery. It took over 4 hours and 3 devices to get a pressure reading, which reportedly delayed the emergency surgery. The pressure reading obtained was between 28-29 mmhg. The complainant also stated that it seemed? Something was missing? From the device as they could not get the transducer connected correctly to remove all of the air from the line. After they obtained a pressure reading, the patient was taken to surgery and expired the next day. The icu nurse manager complained of multiple issues during the use of the device, including that it took too long to set the device up, they did not receive training on the device, and could not get air out of the lines to get a pressure. The patient had originally been admitted for chest pain and a-fib. He was on heparin therapy for a clot in his heart. The facility would not provide the cause of death. Clinical statement: the information provided by the complainant was limited. There was no conclusive evidence relating the device to the patient? S death as it was a medical decision by the physician not to proceed with emergency surgery prior to obtaining the pressure reading. This one event has multiple alleged deficiencies and will be reported in multiple complaints and medwatch reports. This complaint/report is five of five.
Patient Sequence No: 1, Text Type: D, B5
[110225753]
The complaint was unconfirmed. During the visual inspection no obvious defects were noticed in the samples. Per functional assessment the samples were found acceptable. The water flowed through the system without any difficult, and no bubbles were observed. The check valves were found in the correct position and place. No obstruction or leakage was noticed in the samples. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use state the following: "bard? Intra-abdominal pressure monitoring device indications for use: the bard? Intra-abdominal pressure (iap) monitoring device is intended for the monitoring of intra-abdominal pressure via a foley urinary catheter. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (iah) and the associated clinical syndrome of abdominal compartment syndrome (acs). Caution: as an interpretive tool, the bard? Intra-abdominal pressure monitoring device should be used along with other clinical indicators to aid the physician in the diagnosis of intra-abdominal hypertension (iah) and the associated clinical syndrome of abdominal compartment syndrome (acs). Device description: the bard? Intra-abdominal pressure monitoring device is composed of a tubing set used for infusing fluid into the urinary bladder through the foley catheter sampling port. It utilizes a clamping device to occlude the urinary drainage tubing to form a fluid column through which pressure is measured. Important: the bard? Intra-abdominal pressure monitoring device does not include a saline bag, pressure transducer or monitoring system. It adapts to the saline bag, pressure transducer and monitoring system used in your icu. The bard? Intra-abdominal pressure monitoring device must be replaced at the time the urinary catheter and/or urinary drainage tubing is replaced. The bard? Intra-abdominal pressure monitoring device is for use with bard? Foley trays with ez-lok? Sampling port. Contraindications: not for use on pediatric patients. Not for use on patients with compromised bladder function. Warnings: use only saline for pressure measurement. Ensure tubing fluid path is primed so there are no air bubbles. Ensure the iap sampling port is seated tightly to the catheter drainage tubing sampling port prior to use. Precautions: single patient use only. Federal (u. S. A. ) law restricts this device to sale by or on the order of a physician. Latex free. Sterile unless package is damaged or opened. This is a single use device. Do not resterilize any portion of this device. Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient. Sterile contents: 30 cc syringe. Infusion and pressure transducer tubing. Saline bag spike & cap. Zeroing stopcock. Dead-end transducer cap. Proprietary drain tube clamp. Valve port. Check valves for controlling and directing flow. Statlock? Foley device kit. Synthetic gloves. Instructions for use. Step 1: assembling/mounting the bard? Intra-abdominal pressure monitoring device 1. Hang a bag of sterile saline on an iv pole. A pressure cuff is not required. 2. Open the bard? Intra-abdominal pressure monitoring device tray. 3. Don gloves. 4. Mount the statlock? Foley stabilization device on the patient per the enclosed instructions. 5. Open a pressure transducer kit (not included) in sterile fashion and place contents onto the open bard? Intra-abdominal pressure monitoring device tray. Note: the bard? Intra-abdominal pressure monitoring device adapts to the pressure transducer used in your icu. Many pressure transducer variations exist, all which are compatible with the bard? Intra-abdominal pressure monitoring device. Although a flush device is not required, the bard? Intra-abdominal pressure monitoring device can be used with one. Option 2 below is available because many flush devices are permanent or difficult to disconnect from the transducer. Option 1: remove all attachments from the transducer (flush device, drip chamber, truing stopcocks, etc. ) until the transducer has only luer connections. Option 2: leave flush device and/or stopcock attached. Be sure the flush device is attached distally and capped at the end. 6. Grasp the coiled tubing and remove entire assembly from the tray. 7. Verify all tubing connections are secure. 8. Remove the protective cap from the saline spike and insert the spike into the saline bag. 9. Place the syringe on the bed or hang the syringe from the iv pole. 10. Connect the transducer to the end of the tubing labeled? Transducer? Using the provided stopcock as needed depending on the transducer assembly available. 11. Cap the opposite end of the transducer or flush device. 12. Mount the drainage tubing on the clamp. 13. Decide whether the pressure transducer will be mounted on the pole or the patient. Pole-mounted patient-mounted step 2: priming the bard? Intra-abdominal pressure monitoring device priming of the transducer line 1. Remove the end cap from the distal end of the transducer. 2. Open the transducer stopcock. 3. Aspirate approximately 30 ml of saline into the syringe and compress the syringe. 4. Observe fluid passing through the distal end of the transducer. Ensure no air bubbles remain in the tubing to the transducer. 5. Close the distal transducer stopcock. 6. Attach the pressure transducer to the patient or pole. 7. Connect the pressure transducer cable to the pressure transducer. 8. Connect the pressure transducer cable to the monitor. Priming of the valve port line 9. Disconnect and discard the yellow luer cap from the valve port. 10. Aspirate approximately 10 ml of saline into the syringe and compress the syringe until fluid passes through the tubing to the valve port and there is no more fluid within the syringe. Ensure no bubbles remain in the tubing to the valve port. 11. Prepare the connection of the catheter sampling port with antiseptic solution 12. Connect the valve port on the iap device to the sampling port on the catheter. Step 3: measuring bladder pressure with the bard? Intra-abdominal pressure monitoring device zeroing the device 1. Patient must be supine (flat on back). 2. Hold the clamp and rotate the handle clockwise 90 degrees from the? Drain? Position to the? Iap? Position. Caution: be sure to rotate the clamp the complete 90 degrees. The clamp will stop rotating when it is in the correct position. Verify the drain tube is completely kinked by the clamp. 3. Zero the transducer to atmosphere at the level of the pubic symphysis. After zeroing the transducer, ensure the stopcock is open to the transducer. 4. Hold the clamp and rotate the handle counterclockwise 90 degrees from the? Iap? Position to the? Drain? Position. Caution: be sure the clamp has been turned to the? Drain? Position to ensure proper urinary drainage. Obtaining an iap reading 5. Patient must be supine (flat on back). 6. Hold the clamp and rotate the handle clockwise 90 degrees from the? Drain? Position to the? Iap? Position. Caution: be sure to rotate the clamp the complete 90 degrees. The clamp will stop rotating when it is in the correct position. Verify the drain tube is completely kinked by the clamp. 7. Pick up the syringe and aspirate 25 ml of saline into the syringe. Compress the syringe plunger slowly over 20 to 30 seconds, gently infusing the fluid into the bladder. Infuse 25 ml of saline, which is enough to create a fluid column and to remove air from tubing. Larger instillation volumes (>50ml) may cause clinically relevant overestimation of iap. 1 8. Place the syringe on the bed or hang the syringe from the iv pole. 9. Allow the system to equilibrate and then note the pressure reading on the monitor at end expiration. Caution: this reading should not steadily decline. If you find the pressure reading drifts down, then the clamp is likely not rotated the full 90 degrees and fluid is leaking out of the system or you have a luer connector leak. Drain the system, check the luer connections and repeat the process, making sure the clamp is turned a full 90 degrees. 10. Once a reading is completed, hold the clamp and rotate the handle counterclockwise 90 degrees from the? Iap? Position to the? Drain? Position. Caution: be sure the clamp has been turned to the? Drain? Position to ensure proper urinary drainage. When the bard? Intra-abdominal pressure monitoring device clamp is in the? Drain? Position, there may be some pressure left in the system, which reads on the monitor, this is normal. Only after following the above procedure and with the clamp in the? Iap? Position should the monitor be read and interpreted. 11. Record the volume of fluid infused in the fluid i&o? S sheet. Step 4: obtaining a urine sample (optional) 1. Slide the bard? Intra-abdominal pressure monitoring device clamp along the length of the tubing to just below the bead on the tubing. 2. Prep the valve port? S sampling port with antiseptic solution. 3. Hold the bard? Intra-abdominal pressure monitoring device clamp and rotate the handle clockwise 90 degrees from the? Drain? Position to the? Iap? Position. 4. Attach a luer syringe or bd vacutainer to the sampling port luer lock and draw urine samples. 5. Remove the luer syringe or bd vacutainer from the sampling port luer lock. 6. Hold the bard? Intra-abdominal pressure monitoring device clamp and rotate the handle counterclockwise 90 degrees from the? Iap? Position to the? Drain? Position. Caution: be sure the clamp has been turned to the? Drain? Position to ensure proper urinary drainage. 1. Effect of bladder volume on measured intravesical pressure: a prospective cohort study. Critical care. 2006; 10(4): r98. Malbrain ml, deeren dh. " the information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[110225754]
It was reported that it was difficult to get the air bubbles out of the tubing. The complainant reportedly used about 500cc of saline to clear the air bubbles out of the tube. The complainant alleged an accurate reading of the patient's intake/output could not be obtained due to the large volume of saline used to get the air bubbles out. The complainant also reported that it took roughly 30-45 minutes for the set up. Per additional information received on (b)(6) 2018, the patient had developed compartment syndrome, and the surgeon wanted to obtain an intra-abdominal pressure before performing emergency surgery. It took over 4 hours and 3 devices to get a pressure reading, which reportedly delayed the emergency surgery. The pressure reading obtained was between 28-29 mmhg. The complainant also stated that it seemed? Something was missing? From the device as they could not get the transducer connected correctly to remove all of the air from the line. After they obtained a pressure reading, the patient was taken to surgery and expired the next day. The icu nurse manager complained of multiple issues during the use of the device, including that it took too long to set the device up, they did not receive training on the device, and could not get air out of the lines to get a pressure. The patient had originally been admitted for chest pain and a-fib. He was on heparin therapy for a clot in his heart. The facility would not provide the cause of death. Clinical statement: the information provided by the complainant was limited. There was no conclusive evidence relating the device to the patient? S death as it was a medical decision by the physician not to proceed with emergency surgery prior to obtaining the pressure reading. This one event has multiple alleged deficiencies and will be reported in multiple complaints and medwatch reports. This complaint/report is five of five.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-00924 |
| MDR Report Key | 7365297 |
| Report Source | DISTRIBUTOR,OTHER,USER FACILI |
| Date Received | 2018-03-23 |
| Date of Report | 2018-05-23 |
| Date Mfgr Received | 2018-05-21 |
| Date Added to Maude | 2018-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | AMY GRAVLEY |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD? INTRA-ABDOMINAL PRESSURE MONITORING DEVICE |
| Generic Name | IAP MONITORING DEVICE |
| Product Code | PHU |
| Date Received | 2018-03-23 |
| Returned To Mfg | 2018-04-13 |
| Model Number | IAP001 |
| Catalog Number | IAP001 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-03-23 |