Description of Event or Problem · 1
PLACEMENT OF INTR-AORTIC COUNTER PULSATING BALLOON VIA LEFT FEMORAL ARTERY OCCURRED ON 1/22/93. ON 1/27/93 OLD BLOOD DRAINAGE NOTED IN IABP TUBING. TUBING CHANGED FROM PATIENT TO MACHINE. LATER ON 1/27/93 TUBING FROM PATIENT TO SAFETY CHAMBER BEGAN TO HAVE BROWNISH FLUID SPATTERED WITH SMALL CLOTS, CONNECTING TUBING CHANGED. AFTER SECOND CHANGE TUBING AGAIN SHOWED VERY SMALL AMOUNT OF BROWN LIQUID. IABP SHOWED GOOD WAVE FORM. CONDENSATION IN TUBING OBSERVED. ON 1/28/93 SURGEON UNABLE TO REMOVE IABP BALLOON CATHETER. PATIENT EXPIRED 1/28/93.RESULTS OF EVALUATION: FAMILY REFUSED POST MORTEM. PHYSCIAN STATED ONLY WAY TO RETRIEVE THE DEVICE WAS THROUGH SURGICAL REMOVAL. THEREFORE, DEVICE IS NOT AVAILABLE FOR FURTHER EVALUATIONDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.