BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 3243168 · Received July 18, 2013

    Report

    Report Number
    1219343-2013-00055
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 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
    AU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED WHEN THE EVALUATION RESULTS ARE AVAILABLE. (B)(4)..

    Description of Event or Problem · 1

    HAEMONECTICS RECEIVED A COMPLAINT ON (B)(4) 2013 FOR AN ORTHOPAT DEVICE WITH THE DESCRIPTION "DISK BROKEN/ BLOOD IN MACHINE BAG". NO PATIENT OR OPERATOR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335382 ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM CAC HAEMONETICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1