BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM

    MDR report key: 10927332 · Received December 1, 2020

    Report

    Report Number
    1219343-2020-00124
    Event Type
    Injury
    Date Received
    December 1, 2020
    Date of Event
    November 5, 2020
    Report Date
    November 9, 2020
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    CAC
    UDI-DI
    10812747016537
    PMA / PMN Number
    K120586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    HAEMONETICS SENT A FIELD SERVICE ENGINEER TO EVALUATE THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM, SYSTEM WAS DETERMINED TO BE FIT FOR USE. THE LOG FILES FOR THE SYSTEM WERE DOWNLOADED, THERE WAS NO PROBLEM FOUND WITH FIRMWARE/HARDWARE/SOFTWARE. THE CELL SAVER® ELITE SET - 125ML SAMPLE WAS NOT RETURNED TO HAEMONETICS, CUSTOMER CONFIRMED THAT SMAPLE WAS DISCARDED. CUSTOMER STATED THAT THERE WERE NO VISIBLE CRACKS OR LEAKS OBSERVED, WITHOUT PHYSICAL SAMPLE HAEMONETICS IS UNABLE TO CONFIRM OR DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    ON (B)(6) 2020 HAEMONETICS WAS NOTIFIED OF A LONG EMPTY AND AIR DETECTED ERROR ALARM WHICH WAS DISPLAYED ON THE 7TH CYCLE OF THE EMPTY PHASE DURING A PROCEDURE IN THE (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. PATIENT REQUIRED ALLOGENEIC RED BLOOD CELLS DUE TO THE LOSS OF AUTOLOGOUS BLOOD AND PAUSE IN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1394267 CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM CS ELITE PROCESSING KIT, 125ML CAC HAEMONETICS CORPORATION CSE-P-125 0220056 10812747016537

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention