BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM

    MDR report key: 9922315 · Received April 3, 2020

    Report

    Report Number
    1219343-2020-00032
    Event Type
    Malfunction
    Date Received
    April 3, 2020
    Date of Event
    January 28, 2020
    Report Date
    March 9, 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

    NO PATIENT INJURY OR CONSEQUENCE OCCURRED DUE TO THE ERROR OR THE DEVICE STOPPING. THE DEVICE WAS SENT TO THE CUSTOMER-BIOENGINEERING DEPARTMENT. THE CUSTOMER DISCARDED THE BOWL THEREFORE 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 (B)(4).

    Description of Event or Problem · 1

    ON FEBRUARY 6 2020 HAEMONETICS WAS NOTIFIED OF A LONG EMPTY ALARM WHICH HAD OCCURRED ON CYCLE 3 DURING A CELL SAVAGE PROCEDURE, UTILIZING THE CELL SAVER® ELITE® AUTO TRANSFUSION SYSTEM. THE DEVICE STOPPED AS A RESULT OF THE ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383271 CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM CS ELITE PROCESSING KIT, 125ML CAC HAEMONETICS CORPORATION CSE-P-125 0519049 10812747016537

    Patients

    Seq Age Sex Outcome Treatment
    1