Description of Event or Problem · 1
AT 0825, ANESTHESIOLOGIST NOTE A DECLINE IN C02 LEVEL AND BRADYCARDIA. HE TOLD SURGEONS TO STOP AND DIRECTED CARDIOPULMONARY RESUSCITATION. THE PARTIENT WAS UNDER GENERAL ANESTHESIA AND EXPIRED AT 0938. AFTER EXHAUSTIVE EXAMINATION OF EQUIPMENT INVOLVED, ON APRIL 15, 1992, WE OPINED, IN THE ABSENCE OF CONCLUSIVE EVIDENCE, THAT THE SUCTION LINE WAS TRANSPOSED ON THE ROTARY PUMP, FLOWING AIR INTO THE RESECTASCOPE RATHER THAN SUCTIONING FLUID. OTHER EQUIPMENT INVOLVED INCLUDED A BARD GYNE-FLO PUMP (BARD REPRODUCTIVE SYSTEMS), AN ANESTHESIA MACHINE (NORTH AMERICAN DRAGER),BAXTER MEDI-VAC SUCTION CANISTER, AND BAXTER MEDI-VAC CLEAR NONCONDUCTIVE CONNECTING TUBDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-FEB-89. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - INADEQUATE, DESIGN - HUMAN FACTORS, LABELING - DIFFICULT TO READ/SEE, FAILURE TO FOLLOW INSTRUCTIONS. CONCLUSION: USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, INVALID DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.