Description of Event or Problem · 1
PATIENT HAD AN INDWELLING INTRA AORTIC BALLOON CATHETER INSERTED ON 5/25/92 WHICH APPARENTLY STARTED LEAKING ON 5/29/92 AT 0025 CAUSING BLOOD TO DRAIN INTO THE IABP CATHETER AND TUBING. THE NURSE DECREASED THE AUGMENTATION AND ASSIST RATIO WAS DECREASED TO 1:3. THE CATHETER WWAS REMOVED BY THE DOCTOR AND RE-INSERTED AND THE IABP WAS REMOVED FROM SERVICE; SECURED IN A LOCKED AREA AND WAS REPLACED WITH ANOTHER IABP. THE MANUFACTURER WAS CALLED AND A FULL INSPECTION WAS PERFORMED AND WITNESSED. THE PUMP WAS FOUND TO BE IN WORKING ORDER. THE BALLOON CATHETER WAS PICKED UP BY A REPRESENTATIVE FROM DATASCOPE CORP. AND SENT TO THEIR QA SERVICES DEPARTMENT FOR TESTING. IT IS POSSIBLE THEIR WAS A MINUTE HOLE PRESENT AT TIME OF INSERTION AND IT HAD BEEN LEAKING VERY SLOWLY UNTIL THE BLOOD WAS VISABLE IN THE TUBING. THE PATIENT WAS RECEIVING IV FLUIDS AND WAS ON A CARDIAC MONITOR AT THE TIME OF THE INCIDENT.THE PATIENT SUFFERED A PROFOUND COMA POSSIBLY INDUCED BY LEAKING HELIUM, LASTING TWO DAYS. THERE WERE NO RESIDUAL DEFICIT AND TO DATE IS RECOVERING NICELY FROM HER BY-PASS SURGERYDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-APR-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.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, MECHANICAL TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE FAILED DURING ASSEMBLY, DEVICE FAILURE DIRECTLY CAUSED EVENT, NO FAILURE DETECTED AND PRODUCT WITHIN SPECIFICATION, OTHER. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.