BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT PLUS INSTRUMENT

    MDR report key: 20332829 · Received September 30, 2024

    Report

    Report Number
    2184009-2024-00571
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 12, 2024
    Report Date
    September 30, 2024
    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
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE REPORTED MULTIPLE LIQUID QUALITY CONTROL TEST FAILS WAS VERIFIED DURING SERVICE. THE SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE ISSUE AS DESCRIBED, BUT FOUND ERROR CODES TO SUPPORT CUSTOMER STATEMENT. THE SERVICE TECHNICIAN NOTICED THAT ELECTRONIC CONTROLS WERE FINE; PERFORMED FUNCTIONAL TEST AND FOUND FLAG HEIGHT OUTSIDE OF RECOMMENDED LIMITS. THE ISSUE WAS RESOLVED BY ADJUSTING THE FLAG HEIGHT AND PERFORMING MULTIPLE ELECTRONIC CONTROLS AND LIQUID CONTROLS. PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. D9: INSTRUMENT WAS SERVICED AT THE FACILITY BY MEDTRONIC FIELD SERVICE AND WAS NOT RETURNED TO MEDTRONIC SERVICE CENTER MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED MULTIPLE LIQUID QUALITY CONTROL TEST FAILS. THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053978 ACT PLUS INSTRUMENT TIMER, CLOT, AUTOMATED GKN PERFUSION SYSTEMS ACT100 00643169178380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown