BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 3131507 · Received May 14, 2013

    Report

    Report Number
    1219343-2013-00044
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    PMA / PMN Number
    K992723
    Removal / Correction Number
    1219343-04/29/2011-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVALUATION OF "DOES NOT HOLD CHARGE". UPON EVALUATION ON (B)(4) 2013 FLUID INGRESS WAS FOUND. ELECTRONIC COMPONENTS THAT WERE DAMAGED AND REPLACED WERE: THE POWER SUPPLY, CONTROLLER BOARD, DISTRIBUTION PCB, AND CENTRIFUGE ASSY. THE DEVICE WAS UPGRADED TO THE CURRENT FLUID REMEDIATION. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2013 TO REPORT AN ORTHOPAT DEVICE WITH THE DESCRIPTION OF "DOES NOT HOLD CHARGE." NO PATIENT/OPERATOR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213741 ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM CAC HAEMONETICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1