BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM

    MDR report key: 19706654 · Received July 9, 2024

    Report

    Report Number
    1219343-2024-00011
    Event Type
    Malfunction
    Date Received
    July 9, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 9, 2024
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    CAC
    PMA / PMN Number
    K120586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    LOT #1023003 WAS MANUFACTURED ACCORDING TO APPROVED PROCEDURES AND MET ALL SPECIFICATIONS FOR RELEASE, WITH NO NOTED MANUFACTURING DEVIATIONS, NCE'S OR CAPAS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED INCIDENT. THE DEVICE WAS NOT RETURNED AND THEREFORE A ROOT CAUSE COULD NOT BE ESTABLISHED. THERE WAS NO REPORTED ADVERSE EVENT OR PATIENT HARM ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2024, DURING HEART SURGERY, BOWL BASE LEAK AT THE 3RD CYCLE WHILE UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. THE CRACK WAS FOUND AT THE BOWL BASE AND CAUSED LEAKAGE. NO ABNORMAL SOUND WAS HEARD BEFORE THE EVENT. THE INCIDENT CAUSED THE LOSS OF ABOUT 225ML OF BLOOD IN THE CENTRIFUGAL BOWL, AND ABOUT 1,300 ML OF BLOOD IN THE RESERVOIR. AFTER THE INCIDENT, BLOOD WAS URGENTLY TAKEN FROM THE BLOOD BANK TO SUCCESSFULLY COMPLETE THE OPERATION. THERE WAS NO REPORT OF PATIENT HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1349289 CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM CS ELITE PROCESSING KIT, 225ML CAC HAEMONETICS CORPORATION CSE-P-225 1023003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown