Description of Event or Problem · 1
ON JULY 18, 1992, CORONARY CARE UNIT STAFF OBSERVED BACKFLOW OF BLOOD INTO INTRA-AORTIC BALLOON (IAB) CATHETER TUBING AND PUMP. IAB CATHETER AND PUMP WERE REMOVED AND REPLACEMENT CATHETER WAS INSERTED. PREVIOUSLY REMOVED IAB CATHETER WAS EXAMINED AND A HOLE WAS NOTED AT THE PROXIMAL END. BAYSTATE MEDICAL CENTER SUBMITS THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR PART 803. BAYSTATE MEDICAL CENTER HAS NOT DETERMINED THE CAUSE OF THIS PROBLEM. THIS REPORT SHALL NOT BE CONSTRUED AS AN ADMISSION BY BAYSTATE MEDICAL CENTER THAT IT OR ANY OF ITS EMPLOYEES OR AFFILIATES CAUSED OR CONTRIBUTED TO THE INCIDENT DESCRIBED HEREINDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: MATERIAL DEGRADATION/DETERIORATION. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.