BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT PLUS INSTRUMENT

    MDR report key: 11906694 · Received May 31, 2021

    Report

    Report Number
    2184009-2021-00046
    Event Type
    Malfunction
    Date Received
    May 31, 2021
    Date of Event
    May 7, 2021
    Report Date
    May 31, 2021
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    GKN
    UDI-DI
    00643169178380
    PMA / PMN Number
    K940426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS AND INVESTIGATION - THE COMPLAINT IS NOT CONFIRMED FOR THE ACT PLUS INSTRUMENTS REPORTED ERRONEOUS READINGS. THE REPORTED ERRONEOUS READINGS ISSUE WAS NOT VERIFIED DURING SERVICE. SERVICE TECHNICIAN PERFORMED TESTING AND VERIFICATION OF INSTRUMENT AND FOUND FLAG HEIGHT OUT OF TOLERANCE DUE TO MOUNTING SCREW AT BASE OF FLAGS NOT SECURE. TIGHTENED SET SCREW AND FLAG HEIGHT WAS STILL OUT OF LIMITS, ADJUSTED FLAG HEIGHT ADJUSTMENT SET SCREW AND COULD NOT BRING FLAGS INTO CONSISTENT TOLERANCES DUE TO FLAG MOTOR SENSOR CAUSING THE STOP OF THE FLAGS AT THE PEAK OF A STOP. ADJUSTED FLAG POSITION SENSOR, ADJUSTED FLAG HEIGHT TO WITHIN TOLERANCES, PERFORMED PERFORMANCE CHECKS AND WITNESSED LIQUID CONTROLS AGAINST THIS INSTRUMENT AND A SECONDARY INSTRUMENT, WITH ALL CHECKS TESTING WITHIN LIMITS. THE CARTRIDGE FOR CONTROLS WERE FROM THE SAME LOT AND UTILIZED THE SAME CONTROL FOR BOTH INSTRUMENTS, READINGS FOR ABNORMAL WERE ONLY A 3 SECONDS FROM EACH OTHER ON BOTH. TRENDS FOR ISSUES WITH THIS PRODUCT ARE REVIEWED AT QUARTERLY QUALITY MEETINGS. THE ACT PLUS SOFTWARE CONSTANTLY MONITORS FOR SOFTWARE AND/OR HARDWARE FAULTS. WHEN ONE IS FOUND, AN ERROR IS DISPLAYED AND TYPICALLY ADDRESSED BY THE OPERATOR. 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 WAS SUSPICIOUS OF THE READINGS DURING A CASE AND HAD THEM COMPARED TO ANOTHER TWO INSTRUMENT AND FOUND THIS INSTRUMENT TO BE INTERMITTENTLY ERRONEOUS. THE CUSTOMER TRIED THE INSTRUMENT WITH SAME AND DIFFERENT CARTRIDGE LOTS BUT CHANGING THE CARTRIDGE LOT DID NOT RESOLVE THE ISSUE. THE INSTRUMENT WAS CHANGED OUT WITH A BACKUP AND THERE WAS NO RESULTING ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802496 ACT PLUS INSTRUMENT TIMER, CLOT, AUTOMATED GKN PERFUSION SYSTEMS ACT100 00643169178380

    Patients

    Seq Age Sex Outcome Treatment
    1