BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 2854515 · Received November 29, 2012

    Report

    Report Number
    1219343-2012-00177
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 7, 2012
    Report Date
    November 7, 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
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL. A F/U REPORT WILL BE SENT WHEN THE DEVICE IS RETURNED AND EVALUATED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED HAEMONETICS ON (B)(6) 2012 TO REPORT "BLOOD IN CENTRIFUGE/ SERVICE NECESSARY," ON AN ORTHOPAT MACHINE.

    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