BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 2770167 · Received October 1, 2012

    Report

    Report Number
    1219343-2012-00156
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    August 30, 2012
    Report Date
    August 30, 2012
    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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED ON (B)(4) 2012. A FLUID SPILL WITH ELECTRICAL DAMAGE WAS DISCOVERED AND THE COMPLAINT WAS RAISED TO A HIGHER LEVEL REVIEW. A BURNING SMELL WAS ALSO NOTED. AN UNK FLUID SPILLED INTO THE DEVICE CAUSING BURNING ON THE POWER SUPPLY ASSEMBLY AND FUSE. THESE PARTS WERE REPLACED AND THE DEVICE IS READY FOR USE. (B)(4).

    Description of Event or Problem · 1

    HAEMONETICS RECEIVED A COMPLAINT ON (B)(4) 2012 FOR AN ORTHOPAT DEVICE WITH THE DESCRIPTION "MACHINE WILL NOT TURN ON." NO PATIENT/OPERATOR INJURY ASSOCIATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1