MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-04-21 for U0707 TINA SINGLE PUMP NIBPLCD S1000L3P manufactured by Baxter Healthcare - Largo.
[1300574]
On march 29, 2010 baxter field service technician notified the baxter service manager on (b) (6) 2010, the facility head nurse in hospital (b) (6) called him to notify that the system1000l3p machine noted an "air detected' alarm and reportedly the machine emptied the venous chamber too quickly during patient use resulting in the patient requiring medical assistance (unknown interventions). Shortly after the event, the female patient expired on (b) (6) 2010 while in the renal center. The patient reportedly was not receiving medication during the dialysis treatment. The cause of death was not reported. It is unknown if an autopsy was performed. The head nurse stated she was accustomed to seeing this alarm, but that it was not usual or normal for the venous chamber to empty quickly. The head nurse indicated three different blood lines were being used at the dialysis center during this time. One nipro blood line was available. The line was reportedly inserted in the line clamp during the event. An on-site visit was completed by the field service technician on march 29, 2010. The technician noted the "air detected" alarm presented on the screen when the tina machine was turned on. During the visit, the technician found that the membrane of the lower button (switch) of the venous chamber was perforated. After reviewing the button, the technician concluded a sharp object (similar to a pencil) had been used to operate the button causing the button to break the outer membrane. The technician was unable to repair the malfunctioning switch at the time of the on-site visit. The technician verified the operation of the "line clamp" by loading a primed line and induced an air bubble after the venous air chamber by shaking the chamber. The equipment alarmed "air detected" and immediately activated the line clamp and stopped the solution flow. The technician returned on 03/30/2010 to complete servicing of the machine. The technician advised that on previous visits, he had observed clinical personnel using a pencil to actuate the button of the venous chamber. The technician indicated he had advised the facility to not use any object to actuate the buttons.
Patient Sequence No: 1, Text Type: D, B5
[1619844]
On (b) (6) 2010, approximately two hours into the patient's hemodialysis treatment on the tina machine, an alarm was heard and the venous line was found empty. The patient's eyes rolled back and she was not responsive to the nurse calling her name. The physician was notified. Cardiopulmonary resuscitation was initiated. No laboratory tests or scans were performed. Adrenaline, atropine, and aminophylline were administered to the patient (dose unknown). The patient expired the same day. The death certificate indicates respiratory insufficiency as the cause of death. The physician indicated the respiratory insufficiency was due to an embolic event. The certificate of death is not available. An autopsy was not performed. Autopsy is not a standard procedure unless the family requests it by legal means. The patient family did not request an autopsy. On (b) (6) 2010, the patient had a first dose of heparin when the treatment started 0. 5cc (2500 units), and a second dose of 0. 5cc (2500 units) 10 to 15 minutes before the alarm was heard. No other medication was infused that day. This was a (b) (6) female patient. The patient started in dialysis treatment on (b) (6) 2008. An on-site visit was conducted by the baxter field service technician on (b) (6) and (b) (6) 2010. The customer did not report any other alarm to the technician on (b) (6) (b) (6) or (b) (6). The technician did not find any other alarm in the event history or during the on site visit servicing on (b) (6) 2010. On (b) (6) 2010 the technician did not find any malfunction in the equipment, however the technician report states that the venous adjust level switch was perforated. On april 8, 2010, the baxter area service manager met with the physician and dialysis center head nurse. The purpose of the meeting was to collect more information about the patient death that occurred. The baxter renal clinical trainer trained the facility about the safety features of the tina equipment. A demonstration of the functionality of the "air detector" and "line clamp" safety features was provided to the physician. The physician indicated the nursing personnel have been retrained on these features. On (b) (6) 2010, the head nurse was to retrain the nursing personnel that they should not use any "object" to actuate the venous adjust level switch. The air detection alarm is a tina safety feature that detects air bubbles in the venous line (after the air trap chamber and before the line clamp assemble). This safety feature is activated when the tina detects that an air bubble in the bloodlines the customer reported the equipment emptied the venous chamber too quickly and that the venous air trap chamber was below the mid level they were accustomed to seeing. The customer states that in this event the line was emptied to a point that air reached the patient. The bloodlines were setup correctly. No air was seen entering the patient. The head nurse and physician stated that when they arrived at the patient's bed side, they observed that the venous line (from the air trap chamber) was completely empty to the point of entry to the patient. The venous button was inspected and it felt to be more "hard to push" than "sticky". The customer states that the pressure monitoring line (from the venous chamber) was secured to the venous "luer". The transducer protector was connected to the pressure transducer port. The pressure transducer was discarded with the blood lines. The customer reported that the dialysis center experiences continuous voltage fluctuations and that the voltage varies between 80 and 130 volts. During the on-visit, the technician measured the line voltage and recorded voltage fluctuations between 112 and 118 volts. The customer reported that they experience multiple repairs due to this issue, and an uninterruptible power supply (ups) for each dialysis machine had been installed. During the visit, it was observed that three ups (out of the twelve in the hospital dialysis center) were out of service. During the visit on (b) (6) 2010, the tina equipments in use were connected to a functional ups. The customer reported that on occasion the water supply is not sufficient for the number of dialysis equipment installed. Based on the meeting held with the hospital personnel and on observations made during the visit, it appears the tina equipment was operating in unstable conditions. The unstable conditions are due to electrical variations, inconstant water supply conditions, and nursing personnel not following manufacturer operator instructions to use the equipment.
Patient Sequence No: 1, Text Type: D, B5
[8536730]
(b) (4) an on site evaluation was performed by the field service technician on 03/29/10. Results of the evaluation have not been received. A follow-up report will be filed upon completion of an evaluation or if any additional information becomes available. A 510(k) number will not be provided in the emdr as this is an international code for distribution outside of the u. S. But is being reported as it is the same as or similar to a code distributed within the u. S.
Patient Sequence No: 1, Text Type: N, H10
[8632303]
(b) (4). Results of the on site visit on (b) (6) 2010 indicate the following: the technician found the "air detected" alarm appeared when the machine was turned on. The technician found the lower button (switch) of the venous chamber was perforated. Assessment of the switch concluded that a sharp object was used to operate the button which caused the button to break the outer membrane. The technician verified the operation of the "line clamp" by loading a primed line and induced an air bubble. The machine alarmed "air detected" and activated the line clamp and stopped the solution flow. During the diagnostic testing of the unit, an air detected failure was confirmed due to air in the "venous" line. The "venous" line switch was found perforated by an object with a sharp point. The level adjustment switch was replaced. All calibrations were performed. Occlusion and venous line clamp verifications were performed and all tests passed. The device was evaluated and air detected failure test was reproduced. The failure was confirmed. The technician reviewed with the facility that sharp objects should not be used to actuate the switch. The device has software (b) (4). The death certificate indicates respiratory insufficiency as the cause of death. The physician indicated the respiratory insufficiency was due to an embolic event. The certificate of death is not available. An autopsy was not performed. Autopsy is not a standard procedure unless the family requests it by legal means. The patient family did not request an autopsy.
Patient Sequence No: 1, Text Type: N, H10
[19529567]
A customer reported an issue with their freestyle flash meter. Upon product investigation, it was discovered, the meter exhibited the memory overwrite malfunction. There was no report of death, serious injury or mistreatment associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[19751371]
(b)(4). The samples of venous level adjust switch and rubber venous button for tina single pump device (b)(4) were returned for evaluation to the product analysis lab (pal). Samples were received in poor condition: the down arrow of venous button was torn and broken off (unusable) and the dome switch for the venous level adjust down position was damaged and collapsed. The switch was evaluated by using a multimeter for troubleshooting purposes: venous level adjust down switch was found to be stuck closed sometimes, then opened slowly when button was released. Two self tests were performed: checked arterial and venous functionality for tina test fixture prior install of the sample: all tests passed. Installed a venous level adjust switch (sample) to test the article and hard powered on the device to rinse mode then checked level adjust pump operation. The up switch functioned normally. The down switch needed to be pushed extra hard to function properly. Performed self test to test fixture then entered to prime mode and performed arterial, venous and tmp (transmembrane pressure) pressure displays: all tests passed. Entered dialyze mode and checked venous level adjust switch (up and down) with therapy tubing installed: drip chamber operated within specification. Pal performed the evaluation on the return switch and found no problem was noted. The assignable cause for the reported issue of air in bloodlines was undetermined.
Patient Sequence No: 1, Text Type: N, H10
[21742797]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[21784546]
It was reported a motor stall was confirmed. Company rep stated that pump had no indication of a motor stall in the logs. It was stated at least 2 roller studies were attempted and claimed they saw little to no movement of the roller mechanism. It was noted that the pump was planned to be replaced in a couple of weeks. At the time of this report, no further details were reported. Add'l info was requested and will be provided when available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423500-2010-00521 |
| MDR Report Key | 1663326 |
| Report Source | 01,05 |
| Date Received | 2010-04-21 |
| Date of Report | 2010-03-29 |
| Date of Event | 2010-03-19 |
| Date Mfgr Received | 2010-09-20 |
| Date Added to Maude | 2010-09-21 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BAXTER HEALTHCARE - LARGO |
| Manufacturer Street | 7511 114TH AVE. NORTH |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | U0707 TINA SINGLE PUMP NIBPLCD |
| Generic Name | SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2010-04-21 |
| Catalog Number | S1000L3P |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - LARGO |
| Manufacturer Address | 7511 114TH AVE. NORTH LARGO FL 33773 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-04-21 |