BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOPAT CARDIOVASCULAR AUTOTRANSFUSION

    MDR report key: 2465310 · Received February 21, 2012

    Report

    Report Number
    1219343-2012-00065
    Event Type
    Death
    Date Received
    February 21, 2012
    Date of Event
    February 6, 2012
    Report Date
    February 6, 2012
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    PMA / PMN Number
    K05300
    Removal / Correction Number
    1219343-07/14/2011-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6), 2012 TO REPORT THAT THE CARDIOPAT MACHINE WAS NOT DRAINING. A PATIENT DEATH WAS ALSO REPORTED AND IS CURRENTLY BEING INVESTIGATED. NO OPERATOR INJURY WAS REPORTED. A PATIENT DEATH WAS REPORTED IN ASSOCIATION WITH AN ALLEGATION OF DEVICE MALFUNCTION. THERE IS INSUFFICIENT EVIDENCE AT THIS TIME TO CONFIRM OR REFUTE THE REPORTED EVENT. AN INVESTIGATION IS PENDING AND A FOLLOW UP REPORT WILL BE FILED WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6), 2012 TO REPORT THAT THE CARDIOPAT MACHINE WAS NOT DRAINING. A PATIENT DEATH WAS ALSO REPORTED AND IS CURRENTLY BEING INVESTIGATED. NO OPERATOR INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1