BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAEMOTRONIC

    MDR report key: 7602 · Received January 28, 1994

    Report

    Report Number
    7602
    Event Type
    Malfunction
    Date Received
    January 28, 1994
    Date of Event
    September 24, 1993
    Report Date
    October 18, 1993
    Manufacturer
    HAEMOTRONIC LTD.
    Product Code
    FKB
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ONE HOUR AFTER PATIENT BEGAN DIALYSIS TREATMENT ON COBE CENTURY 2RX, BLOOD WAS NOTED TO BE LEAKING FROM THE TOP OF THE ARTERIAL CHAMBER. THE TOP OF THE CHAMBER BECAME COMPLETELY DISCONNECTED. APPROXIMATE BLOOD LOSS WAS 250CC. ARTERIAL TUBING WAS CHANGED AND 300 CC NS GIVEN FOR VOLUME LOST.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY 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.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: OTHER. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAEMOTRONIC BLOOD TUBING FKB HAEMOTRONIC LTD. TS 505/2 B93870 OR B924270

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other