BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS ITALIAN

    MDR report key: 23221022 · Received October 6, 2025

    Report

    Report Number
    2184009-2025-01281
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    October 3, 2025
    Report Date
    October 31, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    PMA / PMN Number
    K101271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION:THE REPORTED ACT VALUES NOT REAL,ACT VALUES NOT CONSISTENT WITH EXPECTED ONES AND MOTOR STALL L/R WAS VERIFIED DURING SERVICE. THE ISSUE WAS RESOLVED BY REPLACING THE ADU CONTROLLER BOARD.SERVICE TECHNICIAN EXECUTED ALL FUNCTIONAL TESTS ACCORDING TO THE PROCEDURE DESCRIBED IN THE TECHNICAL MANUAL.PERFORMED ELECTRICAL SAFETY TESTS, HOME POSITION CALIBRATION, AND TEMPERATURE CHECK.SERVICE TECHNICIAN CARRIED OUT HEPTRAC TESTS WITH POSITIVE RESULTS.POST REPAIR TESTING WAS PERFORMED PER SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 0

    CORRECTION H4: DEVICE MFG DATE ADDED. 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

    DURING TESTING/ MAINTENANCE BY A SERVICE TECHNICIAN THIS HMS PLUS INSTRUMENT HAD ACTIVATED CLOTTING TIME (ACT) VALUES THAT WERE NOT REAL ,ACT VALUES WERE NOT CONSISTENT WITH EXPECTED ONES AND THERE WAS A MOTOR STALL L/R.THIS WAS DETECTED DURING SERVICE SO THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2353285 HMS PLUS ITALIAN ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown