BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 2180711 · Received May 5, 2011

    Report

    Report Number
    1219343-2011-00019
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 5, 2011
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    PMA / PMN Number
    K992723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE EQUIPMENT WAS REPAIRED, INTERNAL ELECTRONIC PARTS WERE REPLACED, WHICH IS CONSISTENT WITH AN ELECTRICAL SHORT CIRCUIT. NO PT OR OPERATOR INJURY WAS NOTED IN THE SERVICE/COMPLAINT RECORDS.

    Description of Event or Problem · 1

    THE CUSTOMER(S) RETURNED THE ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM FOR REPAIR DUE TO FLUID INGRESS. FLUID INGRESS RESULTED IN ELECTRONIC FAILURE DUE TO SHORT CIRCUIT. NO PT OR OPERATOR INJURY WAS NOTED IN THE SERVICE/COMPLAINT RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM PERIOPERATIVE AUTOTRANSFUSION SYSTEM CAC HAEMONETICS CORP. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention