BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM

    MDR report key: 2234213 · Received August 31, 2011

    Report

    Report Number
    1219343-2011-00167
    Event Type
    Death
    Date Received
    August 31, 2011
    Date of Event
    June 6, 2011
    Report Date
    August 31, 2011
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO ACQUIRE THE CLINICAL DETAILS, THE MACHINE, DISPOSABLES AND SOLUTIONS USED DURING THE PROCEDURE HAVE BEEN MADE WITH NO INFO PROVIDED TO DATE. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2011 AND REPORTED THAT A PT UNDERWENT A METAL ON METAL TOTAL HIP REPLACEMENT (THR) USING THE ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM AND WENT INTO CARDIAC ARREST SHORTLY AFTER THEY WERE REINFUSED WITH WASHED BLOOD. THE PT HAS SUBSEQUENTLY DIED. NO OPERATOR INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death