COBE PERFUSION PACK

Description of Event or Problem

PATIENT RECEIVED AIR EMBOLI DURING OPEN HEART SURGERY DUE TO ALLEGED MISASSEMBLY OF PERFUSION PACK TUBING BY MANUFACTURER. TUBING WAS INSPECTED BY COBE'S DIRECTOR OF QUALITY AND THEIR CARDIOVASCULAR SPECIALIST AFTER INCIDENT. PATIENT WAS TRANSFERRED TO INTENSIVE CAREDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, A DEVICE FROM SAME LOT WAS EVALUATED, MECHANICAL TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INADEQUATE QUALITY ASSURANCE, MANUFACTURING, TUBING. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.