BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 23197500 · Received October 2, 2025

    Report

    Report Number
    2184009-2025-01267
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    August 22, 2025
    Report Date
    October 2, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    PMA / PMN Number
    K111339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION:UPON ACCEPTANCE, NO ABNORMALITIES WERE OBSERVED IN THE CURRENT OPERATION. THE ERROR HISTORY WAS VERIFIED AND FOUND THAT THE ERROR OCCURRED SEVERAL TIMES DURING THE OPERATION OF THE ACTUATOR. THE ISSUE WAS RESOLVED BY REPLACING THE HOLDING SPRING AND THE X-AXIS/Y-AXIS DRIVE BELTS. THE ACTUATOR WAS DISASSEMBLED AND ADJUSTED AND THEN GREASED UP.POST REPAIR TESTING WAS PERFORMED PER SPECIFICATIONS. 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 DURING USE, THIS HMS PLUS INSTRUMENT HAD A MEASUREMENT FAILURE WHEN THE GOLD CARTRIDGE WAS USED.THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT . MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NEITHER LIQUID NOR ELECTRONIC (ACTTRAC OR HEPTRAC) CONTROLS WERE USED .QUALITY CONTROL IS ONLY PERFORMED DURING ANNUAL MAINTENANCE INSPECTIONS .THERE WAS NO ERROR CODE ASSOCIATED WITH THIS ISSUE AND NO CONTROL VALUES WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2426644 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown