BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM

    MDR report key: 11934760 · Received June 3, 2021

    Report

    Report Number
    1219343-2021-00024
    Event Type
    Injury
    Date Received
    June 3, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 4, 2021
    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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    HAEMONETICS SENT A FIELD SERVICE ENGINEER TO EVALUATE THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM, IT WAS DETERMINED THAT THERE WAS NO DETECTED PROBLEM WITH THE SYSTEM. CUSTOMER STATED THAT THE BOWL WAS INSPECTED AND NO VISIBLE CRACKS WERE OBSERVED. ALTHOUGH NO CRACKS WERE DETERMINED BY CUSTOMER, HAEMONETICS DID NOT RECEIVE THE SAMPLE BACK FOR EVALUATION TO DETERMINE CAUSE.

    Description of Event or Problem · 1

    ON MAY 04, 2021 HAEMONETICS WAS NOTIFIED OF A LONG HOUR RETURNING ERROR WHICH WAS OBSERVED DURING A VASCULAR PROCEDURE IN (B)(6), UTILIZING THE CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM AND CELL SAVER® ELITE SET - 125ML. DURING THE PROCEDURE IT WAS ALSO NOTED THAT THERE WERE PRIOR ERROR MESSAGES OF PRESSURE IN BLUE LINE AND FLUID DETECTED EARLY. THERE WAS 293MLS OF BLOOD WAS LOST, AND PATIENT DID REQUIRE A POST-OPERATIVE TRANSFUSION. CUSTOMER STATED THERE WERE UNABLE TO PROVIDE CURRENT PATIENT HEALTH STATUS DUE TO CONFIDENTIALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831456 CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM CELL SAVER ELITE SET - 125ML CAC HAEMONETICS CORPORATION CSE-P-125 0820012 10812747016537

    Patients

    Seq Age Sex Outcome Treatment
    1 Other