BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 2201639 · Received August 4, 2011

    Report

    Report Number
    1219343-2011-00110
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 11, 2011
    Report Date
    August 4, 2011
    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
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO HAEMONETICS ON (B)(4) 2011. UPON EVALUATING THE DEVICE FLUID INGRESS WAS FOUND. THE FLUID INGRESS RESULTED IN DAMAGE TO ELECTRONIC COMPONENTS. IT COULD NOT BE CONFIRMED WHETHER THE SPILL BAGS WERE DEPLOYED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2011 AND ALLEGED A DISK LEAK OCCURRED DURING POST-OP RESULTING IN A BURNING SMELL AND BLOOD LEAKING FROM THE BOTTOM OF THE MACHINE ON THE ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM. NO PT INJURY WAS REPORTED. NO OPERATOR INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI