ARTERIAL BLOOD TUBING

Description of Event or Problem

HEPARIN LINE FOR PUMP FELL OFF. PT. LOST BLOOD FROM LINE OPENNINGDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING 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. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN. CONCLUSION: DEVICE FAILURE DIRECTLY CONTRIBUTED TO EVENT, DEVICE DISCARDED - UNABLE TO FOLLOW-UP. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.