BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL SAVER ELITE AUTOTRANSFUSION SYSTEM

    MDR report key: 11670400 · Received April 15, 2021

    Report

    Report Number
    1219343-2021-00109
    Event Type
    Injury
    Date Received
    April 15, 2021
    Date of Event
    February 25, 2021
    Report Date
    March 15, 2021
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    CAC
    UDI-DI
    30812747016548
    PMA / PMN Number
    K120586
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    HAMEONETICS RECEIVED THE UNIT FOR EVALUATION. A SUBMERSION LEAK TEST WAS PERFORMED AND A SMALL MICRO LEAK WAS IDENTIFIED ON A SECTION OF THE LEFT TUBING PORT.

    Description of Event or Problem · 1

    ON MARCH 15 2021, HAEMONETICS WAS NOTIFIED OF A BLOOD LEAK OF APPROXIMATELY 400ML WHICH OCCURRED DURING A PROCEDURE IN FRANCE, UTILIZING THE CELL SAVER® 5 AUTOLOGOUS RECOVERY SYSTEM AND CELL SAVER® 5 SET - 225ML. THE BLOOD LEAK OCCURRED AT THE CONNECTION BETWEEN THE TRANSFUSION BAG AND THE TUBING. THE PROCEDURE WAS DISCONTINUED, PATIENT REFUSED BLOOD TRANSFUSION ALTHOUGH HEMOGLOBIN THRESHOLD JUSTIFIED IT. THE PATIENT EXPERIENCED LONGER CONVALESCENCE AND HOSPITALIZATION DUE TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569749 CELL SAVER ELITE AUTOTRANSFUSION SYSTEM CS ELITE PROCESSING KIT, 225ML CAC HAEMONETICS CORPORATION CSE-P-225 0620022 30812747016548

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization