Description of Event or Problem · 1
ON FEBRUARY 12, 1993 WAS ADVISED OF TWO SEPARATE INSTANCES WHEN TUBING WAS SEVERED COMPLETELY BY THE METAL CLIP THAT PINCHES TUBING WHERE IT EXITS. EVALUATION TO ASCERTAIN THE MECHANICAL CAUSE OF THESE OCCURRENCES WAS UNDERTAKEN ON FEBRUARY 16, 1993. A SERIOUS PATIENT BLEED NECESSITATING BLOOD TRANSFUSION RESULTED FROM ONE OF THESE OCCURRENCES.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.