Description of Event or Problem · 1
ON MAY 19, 1994, A PATIENT WAS TRANSFERRED FROM A LOCAL HOSPITAL ON A IABP AND WAS THEN TAKEN OFF AND PUT ON ANOTHER IABP FROM A DIFFERENT MANUFACTURER. THE ADAPTER THAT WAS SUPPLIED TO ALLOW THE TUBING TO BE PUT ON A PUMP WAS USED. WHEN THE NURSE WAS ROLLING THE PATIENT ON HIS SIDE, THE PUMP BEGAN ALARMING. THE NURSE THEN NOTICED THAT THE ADAPTER HAD BROKEN. ANOTHER ADAPTER WAS PUT ON THE TUBING, AND PUMPING CONTINUED. THE BROKEN ADAPTER WAS DISCARDED AND COULD NOT BE SENT BACK TO THE MANUFACTURER.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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.INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.