BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYPO PACK BY TERUMO

    MDR report key: 1840473 · Received September 10, 2010

    Report

    Report Number
    1840473
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 31, 2010
    Manufacturer
    TERUMO
    Product Code
    DWF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING CARDIOPULMONARY BYPASS, THE ARTERIAL LINE BECAME DISCONNECTED AT THE MANUAL CONNECTION SITE, EVEN THOUGH THE SITE WAS BANDED. APPROXIMATELY 200 CC OF OXYGENATOR PUMP BLOOD WAS NOTED ON FLOOR, CORRECTIVE MEASURES WERE TAKEN AND BYPASS WAS REESTABLISHED. THE TUBING IS TOO SLICK MAKING CONNECTION UNSAFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYPO PACK BY TERUMO BYPASS TUBING DWF TERUMO * MG04 AND MG14

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR