BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM

    MDR report key: 9978739 · Received April 20, 2020

    Report

    Report Number
    1219343-2020-00038
    Event Type
    Malfunction
    Date Received
    April 20, 2020
    Date of Event
    December 18, 2019
    Report Date
    January 28, 2020
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    CAC
    UDI-DI
    10812747016537
    PMA / PMN Number
    K120586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO CONSEQUENCE OR INJURY TO THE PATIENT FOR THIS EVENT. ALTHOUGH THERE WAS A LONG EMPTY ALARM ON CYCLE 11 AND THE CYCLES CONTINUED UNTIL THE END OF THE OPERATION, THE CUSTOMER DID NOT FOLLOW THE GUIDANCE TO STOP THE CELL SALVAGE UPON RECEIVING A LONG EMPTY ALARM. THE DEVICE WAS SENT TO THE CUSTOMERS BIOENGINEERING DEPARTMENT. THE CUSTOMER DID NOT INSPECT THE BOWL FOR CRACKS AND DISCARDED THE BOWL, WHICH COULD NOT BE EVALUATED BY HAEMONETICS. HOWEVER, PER INVESTIGATION THE MOST LIKELY CAUSE OF THE ERROR IS THE BOWL AND IS ASSOCIATED WITH SAFETY NOTICE CRL-100260-IE (MHRA FSCAFY20- 01).

    Description of Event or Problem · 1

    ON (B)(6) 2020, HAEMONETICS WAS INFORMED BY THE CUSTOMER OF A DEVICE MALFUNCTION RECEIVING A LONG EMPTY STARTED AT CYCLE 11 AND CONTINUING (EACH CYCLE) UNTIL THE OPERATION FINISHED AT CYCLE 20.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442583 CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM CS ELITE PROCESSING KIT, 125ML, CAC HAEMONETICS CORPORATION CSE-P-125 0519023 10812747016537

    Patients

    Seq Age Sex Outcome Treatment
    1