| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | BARD? INTRA-ABDOMINAL PRESSURE MONITORING DEVICE | IAP MONITORING DEVICE | C.R. BARD, INC. (COVINGTON) -1018233 | PHU | IAP001 | IAP001 | NGAY4796 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-02-20 | 0 | 1. D |
Patient 1
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. THE DEVICE WAS NOT RETURNED.
Patient 1
IT WAS REPORTED THAT IT WAS DIFFICULT TO GET THE AIR BUBBLES OUT OF THE TUBING, COMPLAINANT REPORTEDLY USED ABOUT 500CC OF SALINE TO CLEAR THE AIR BUBBLES OUT THE TUBE. 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. COMPLAINANT REPORTED THAT IT TOOK ROUGHLY 30-45 MINS TO FOR SET UP.
Patient 1
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 1
IT WAS REPORTED THAT IT WAS DIFFICULT TO GET THE AIR BUBBLES OUT OF THE TUBING, COMPLAINANT REPORTEDLY USED ABOUT 500CC OF SALINE TO CLEAR THE AIR BUBBLES OUT THE TUBE. 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. COMPLAINANT REPORTED THAT IT TOOK ROUGHLY 30-45 MINS TO FOR SET UP. PER ADDITIONAL INFORMATION RECEIVED ON 03/15/2018, 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 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. BASED ON THE ADDITIONAL INFORMATION, THIS COMPLAINT HAS BEEN DETERMINED TO BE A CASCADING EVENT; THEREFORE AN ADDITIONAL COMPLAINT FOR THE UNKNOWN LOT NUMBERS WILL NOT BE OPENED. 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 THREE OF FIVE.
Patient 1
THE COMPLAINT WAS UNCONFIRMED. DURING THE VISUAL INSPECTION NO OBVIOUS DEFECTS WERE NOTICED IN THE SAMPLE. 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 DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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: THIRTY 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. HANG A BAG OF STERILE SALINE ON AN IV POLE. A PRESSURE CUFF IS NOT REQUIRED. OPEN THE BARD? INTRA-ABDOMINAL PRESSURE MONITORING DEVICE TRAY. DON GLOVES. MOUNT THE STATLOCK? FOLEY STABILIZATION DEVICE ON THE PATIENT PER THE ENCLOSED INSTRUCTIONS. 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. GRASP THE COILED TUBING AND REMOVE ENTIRE ASSEMBLY FROM THE TRAY. VERIFY ALL TUBING CONNECTIONS ARE SECURE. REMOVE THE PROTECTIVE CAP FROM THE SALINE SPIKE AND INSERT THE SPIKE INTO THE SALINE BAG. PLACE THE SYRINGE ON THE BED OR HANG THE SYRINGE FROM THE IV POLE. CONNECT THE TRANSDUCER TO THE END OF THE TUBING LABELED ?TRANSDUCER? USING THE PROVIDED STOPCOCK AS NEEDED DEPENDING ON THE TRANSDUCER ASSEMBLY AVAILABLE. CAP THE OPPOSITE END OF THE TRANSDUCER (FIGURES 1 & 2) OR FLUSH DEVICE. MOUNT THE DRAINAGE TUBING ON THE CLAMP. DECIDE WHETHER THE PRESSURE TRANSDUCE...
Patient 1
IT WAS REPORTED THAT IT WAS DIFFICULT TO GET THE AIR BUBBLES OUT OF THE TUBING, COMPLAINANT REPORTEDLY USED ABOUT 500CC OF SALINE TO CLEAR THE AIR BUBBLES OUT THE TUBE. 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. COMPLAINANT REPORTED THAT IT TOOK ROUGHLY 30-45 MINS TO FOR SET UP. IT WAS LATER REPORTED 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 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. BASED ON THE ADDITIONAL INFORMATION, THIS COMPLAINT HAS BEEN DETERMINED TO BE A CASCADING EVENT; THEREFORE AN ADDITIONAL COMPLAINT FOR THE UNKNOWN LOT NUMBERS WILL NOT BE OPENED. 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 THREE OF FIVE.