Description of Event or Problem · 1
PATIENT WAS TRANSFERRED TO CATH LAB AT 10:27 WITH NS AND CATHETER IN PLACE FOR PERICARDIO CENTESIS. AT 11:00 PATIENT WENT INTO DISTRESS AND WAS APRONOUNCED DEAD AT 11:44. CATHETER WAS INSTALLED ON 3/23/93 FOR THE ADMINISTRATION OF IV'S. PATIENT WAS ON NORMAL SALINE. PROPER PLACEMENT OF CATHETER WAS VERFIED BY X-RAY AND AUTOPSY. DURING AUTOPSY IT WAS DISCOVERED THAT THE CATHETER HAD PERFORATED DTHE RIGHT ATRIUM AND THE PATIENT HAD BLED INTERNALLY.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, NONE OR UNKNOWN, UNANTICIPATED ADVERSE REACTION - SHORT TERM. CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP, THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.