BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELL SAVER ELITE AUTOTRANSFUSION SYSTEM

    MDR report key: 10252297 · Received July 9, 2020

    Report

    Report Number
    1219343-2020-00064
    Event Type
    Death
    Date Received
    July 9, 2020
    Date of Event
    May 20, 2020
    Report Date
    June 10, 2020
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    CAC
    UDI-DI
    30812747016357
    PMA / PMN Number
    K120586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    B5: FOLLOWING SECTION WAS UPDATED TO INCLUDE ALL AVAILABLE INFORMATION.

    Description of Event or Problem · 0

    MULTIPLE ERROR MESSAGES WERE DISPLAYED ON THE SYSTEM: LONG EMPTY, AIR DETECTED EARLY, AND PARTIAL BOWL.

    Additional Manufacturer Narrative · 1

    LIMITED PATIENT INFORMATION WAS PROVIDED AT THIS TIME. HAEMONETICS SENT A FIELD SERVICE ENGINEER TO EVALUATE THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM IN ORDER TO CHECK FOR ANY FAULTS, THE MACHINE WAS FOUND TO MEET SPECIFICATIONS AND DID NOT HAVE ANY DEFECTS WHICH REQUIRED REPAIR. THERE WAS NO EVIDENCE OF A DEVICE MALFUNCTION FOUND.

    Description of Event or Problem · 1

    ON JUNE 10 2020 HAEMONETICS WAS NOTIFIED OF A PATIENT FATALITY WHICH HAD OCCURRED WITHIN 48 HOURS OF THE PATIENTS' PROCEDURE, UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 225ML. A LONG EMPTY ERROR MESSAGE WAS DISPLAYED ON THE 6TH CYCLE OF THE RETURN PROCESS, CYCLES WERE CONTINUED TILL END OF OPERATION. A TOTAL BLOOD VOLUME OF 1748ML WAS PROCESSED AND THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH. THE CAUSE OF DEATH WAS REPORTED TO BE UNKNOWN, A COPY OF THE CORONER'S REPORT WAS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714298 CELL SAVER ELITE AUTOTRANSFUSION SYSTEM CS ELITE PROCESSING KIT, 225ML CAC HAEMONETICS CORPORATION CSE-P-225 0618031 30812747016357

    Patients

    Seq Age Sex Outcome Treatment
    1 Death