BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT PLUS INSTRUMENT

    MDR report key: 12583159 · Received October 6, 2021

    Report

    Report Number
    2184009-2021-00088
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    September 9, 2021
    Report Date
    October 6, 2021
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    GKN
    UDI-DI
    00643169178380
    PMA / PMN Number
    K940426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS PERFORMED AT CUSTOMER SITE, INSTRUMENT WAS NOT RETURNED TO MEDTRONIC FOR ANALYSIS. DATE FIELD SERVICE PROVIDED ADDED AS RETURN DATE IN ANALYSIS SHOWS THE REPORTED GREATER THAN 12% VARIATION DURING PATIENT TESTING WAS NOT VERIFIED. FIELD SERVICE TECHNICIAN COULD NOT FIND ANY INSTRUMENT ISSUES. THE TECHNICIAN PERFORMED PREVENTIVE MAINTENANCE AND TESTING PER PROCEDURE AND RETURNED THE INSTRUMENT TO SERVICE. TRENDS FOR ISSUES WITH THIS PRODUCT ARE REVIEWED AT QUARTERLY QUALITY MEETINGS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS ACT PLUS INSTRUMENT THE CUSTOMER REPORTED THAT THEY WERE GETTING GREATER THAN 12% VARIATION DURING PATIENT TESTING. THE CUSTOMER STATED THAT THE ELECTRONIC CONTROL THE ACTTRAC WAS FINE AND LIQUID QUALITY CONTROLS WERE FAILING OR ALMOST FAILING FREQUENTLY. THE INSTRUMENT WAS CHANGED OUT WITH A BACKUP AND THERE WAS NO REPORTED ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482008 ACT PLUS INSTRUMENT TIMER, CLOT, AUTOMATED GKN PERFUSION SYSTEMS ACT100 00643169178380

    Patients

    Seq Age Sex Outcome Treatment
    1