BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT

    MDR report key: 3122025 · Received May 14, 2013

    Report

    Report Number
    MW5030231
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 5, 2013
    Report Date
    May 14, 2013
    Manufacturer
    HAEMONETICS CORP
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    "RUN" KEPT SHUTTING OFF AND WILL NOT STAY ON. ALL CONNECTIONS DOUBLE CHECKED. ORTHOPAT CONVERTED TO HEMOVAC. UPON TAKING DOWN ORTHOPAT, BLOOD FOUND POOLED INSIDE WHERE CENTRIFUGE IS LOCATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213508 ORTHOPAT ORTHOPAT CAC HAEMONETICS CORP ORTHOPAT @277

    Patients

    Seq Age Sex Outcome Treatment
    1