BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLCOTRANS PLUS

    MDR report key: 59914 · Received December 27, 1996

    Report

    Report Number
    1213643-1996-00045
    Event Type
    Malfunction
    Date Received
    December 27, 1996
    Date of Event
    December 4, 1996
    Report Date
    December 27, 1996
    Manufacturer
    DIAVOL, INC.
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    VACUUM TUBE ASSEMBLY, CAP TO THE BACTERIAL AIR FILTER WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLCOTRANS PLUS AUTOTRANSFUSION APPARATUS CAC DIAVOL, INC. NA 41EFDS02

    Patients

    Seq Age Sex Outcome Treatment
    1 *