BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOPAT CARDIOVASCULR AUTOTRANSFUSION

    MDR report key: 3022963 · Received March 21, 2013

    Report

    Report Number
    1219343-2013-00024
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    PMA / PMN Number
    K053000
    Removal / Correction Number
    1219343-07/14/2011-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVAL. A FOLLOW-UP REPORT IS REQUIRED WHEN THE DEVICE HAS BEEN RETURNED AND EVALUATED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2013 TO REPORT "SPILL POST-OP" ON THEIR CARDIOPAT MACHINE. NO DONOR OR OPERATOR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118308 CARDIOPAT CARDIOVASCULR AUTOTRANSFUSION CAC HAEMONETICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1