BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 23369741 · Received October 23, 2025

    Report

    Report Number
    2184009-2025-01359
    Event Type
    Malfunction
    Date Received
    October 23, 2025
    Date of Event
    October 20, 2025
    Report Date
    November 7, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    UDI-DI
    00673978698793
    PMA / PMN Number
    K111339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THIS ISS NOT AN INSTRUMENT ISSUE; IT IS A SOFTWARE PROBLEM RELATED TO RETRIEVING REPORTS FROM PREVIOUS QUALITY CONTROL RUNS. ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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

    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 A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE UNIT FAILS QUALITY CONTROL TEST, AND IS UNABLE TO PRINT QC TEST RESULTS. 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
    2777586 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514 00673978698793

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown