BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM

    MDR report key: 10941382 · Received December 3, 2020

    Report

    Report Number
    1219343-2020-00127
    Event Type
    Injury
    Date Received
    December 3, 2020
    Date of Event
    November 24, 2020
    Report Date
    November 25, 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 IN ORDER TO CHECK FOR ANY FAULTS, THE MACHINE WAS FOUND TO MEET SPECIFICATIONS AND DID NOT HAVE ANY DEFECTS WHICH REQUIRED REPAIR. THE CELL SAVER® ELITE SET - 125ML SAMPLE WAS NOT RETURNED TO HAEMONETICS. 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 RETURNING ERROR ALARM WHICH WAS DISPLAYED DURING AN EMERGENCY C SECTION PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. HAMEONETICS WAS ALSO NOTIFIED OF FLUID COMING UP FROM THE WASTE BAG. BLOOD WAS DISCARDED DUE TO CONTAMINATION CONCERNS, THERE WAS A REPORTED BLOOD LOSS OF 800ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1406874 CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM CS ELITE PROCESSING KIT, 125ML CAC HAEMONETICS CORPORATION CSE-P-125 0320055 10812747016537

    Patients

    Seq Age Sex Outcome Treatment
    1 Other