Description of Event or Problem · 1
A 41-YEAR-OLD MALE UNDERWENT AN ELECTIVE LUMBAR LAMINECTOMY L4-L5 AND SPINAL FUSION WITH SPINAL INSTRUMENTATION AND RIGHT ILIAC BONE GRAFT. AUTOTRANSFUSION DEVICE WAS INSERTED INTO LAMINECTOMY INCISION. POST-OP PT TRANSFERRED TO ICU 6/14/94 AT 2245. APPROX 0145 NURSE HUNG 150 CC BLOOD VIA DEVICE WITH FILTER AND BLOOD SET WITH 80 MICRON FILTER TO INFUSE VIA PERIPHERAL IV. ANOTHER NURSE, RELIEVING FOR PRIMARY NURSE, NOTED BLOOD NOT INFUSING; APPLIED INFUSABLE PRESSURE INFUSER TO BAG; INFLATED BUT BLOOD DID NOT GO IN; DEFLATED AND REINFLATED, HEARD "WHOOSH" AND BLOOD WENT IN. PT SAT UP AND ASKED WHAT WAS HAPPENING, FELL BACK AND HAD CARDIAC ARREST. AFTER 45 MIN, UNABLE TO RESUSCITATE; PRONOUNCED DEAD AT 0245. AUTOPSY REVEALED AIR EMBOLI.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS. THE DEVICE WAS DESTROYED/DISPOSED OF.