Description of Event or Problem · 1
PATIENT WAS UNDERGOING REPAIR OF THE LEFT ACETABULUM ON 7/24/92. DUE TO A SIGNIFICANT BLOOD LOSS, THE PATIENT RECEIVED MULTIPLE TRANSFUSIONS, INCLUDING CELL-SAVERBLOOD WAS BEING INFUSED, THE PATIENT'S BLOOD PRESSURE DROPPED PRECIPITOUSLY. THE PATIENT'S END TIDAL CO/2 WAS NOTED TO DROP. AT THE TIME, THE PRESENCE OF AIR WAS NOTED IN THE EXTENSION TUBING, CONFINED TO THE AREA BETWEEN THE STOPCOCK AND THE PATIENT. THE STOPCOCK WAS UTILIZED WITH THE STANDARD EXTENSION TUBING AND A 16 GUAGE IV CATHETER, PLACED IN THE PATIENT'S RIGHT HAND.THE PATIENT ARRESTED, AND ATTEMPTS AT RESUSCITATION WERE UNSUCCESSFUL. THE MEDICAL EXAMINER'S REPORT INDICATED THAT THE PATIENT SUFFERED A VENOUS AIR EMBOLISM ASSOCIATED WITH HER AUTOTRANSFUSION. INVESTIGATIVE REPORTS FROM MEDICAL STAFF RECEIVED 9/16/92 SUGGEST THAT AIR MAY HAVE ENTERED THE SYSTEM THROUGH THE STOPCOCK, A RESULT OF A COMBINATION OF BERNOULLI AND VENTURI EFFECTDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.