BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM

    MDR report key: 10116295 · Received June 3, 2020

    Report

    Report Number
    1219343-2020-00042
    Event Type
    Malfunction
    Date Received
    June 3, 2020
    Date of Event
    May 13, 2020
    Report Date
    May 13, 2020
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    CAC
    PMA / PMN Number
    K120586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION WAS PROVIDED AT THIS TIME. THE BOWL FROM THE CELL SAVER ELITE SET WAS RETURNED AND EVALUATED BY HAEMONETICS. IT WAS NOTED DURING INVESTIGATION THAT BLOOD WAS SEEN ON THE INNER CORE. BOWL DECOMPRESSION TESTING CONFIRMED THE BLOOD OUTFLOW FROM THE INNER CORE AND THE OUTER CORE WELDING AND SEVERAL CRACKS CONFIRMED IN THE INNER CORE OF BOWL.

    Description of Event or Problem · 1

    ON (B)(6) 2020 HAEMONETICS WAS NOTIFIED OF A LONG EMPTY ERROR MESSAGE WHICH WAS DISPLAYED ON THE 5TH CYCLE OF THE RETURN PROCESS DURING A CARDIAC PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER ELITE AUTOTRANSFUSION SYSTEM AND CELL SAVER ELITE SET - 125ML. A TOTAL BLOOD VOLUME OF 6000ML WAS PROCESSED AND THERE WAS NO REPORTED IMPACT TO PATIENTS' HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579437 CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM CELL SAVER ELITE SET - 125ML CAC HAEMONETICS CORPORATION CSE-P-125-JA 0120047

    Patients

    Seq Age Sex Outcome Treatment
    1