BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOPAT CARDIOVASCULAR AUTOTRANSFUSION

    MDR report key: 2915596 · Received January 10, 2013

    Report

    Report Number
    1219343-2013-00003
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 13, 2012
    Report Date
    December 13, 2012
    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
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. EVIDENCE OF FLUID INGRESS WAS FOUND. THE ELECTRICAL COMPONENTS REPLACED DUE TO THE INGRESS ARE: POWER SUPPLY, CENTRIFUGE, DISTRIBUTION PCB, AC HARNESS, AC FILTER, TOP DECK AND CHASSI. THE DEVICE WILL BE CLEANED, REPAIRED AND UPGRADED BEFORE RETURNING TO CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2012 TO REPORT A CARDIOPAT DEVICE WITH DESCRIPTION ¿BLOOD SPILL.¿ NO PATIENT/OPERATOR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14508 CARDIOPAT CARDIOVASCULAR AUTOTRANSFUSION CAC HAEMONETICS CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1