BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 24265827 · Received February 5, 2026

    Report

    Report Number
    2184009-2026-00209
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 29, 2026
    Report Date
    February 19, 2026
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    PMA / PMN Number
    K101271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT BOTH ELECTRONIC AND LIQUID QUALITY CONTROLS WERE RUN. THE CONTROL FAILURE WAS DUE TO THE SYRINGE PLUNGER STOPPING MID-TEST, AND A MOTOR STALL ERROR WAS DISPLAYED ON THE SCREEN. THE SYRINGE WAS RETURNED TO THE STARTING POSITION. THE ACCOUNT ATTEMPTED TO REPEAT THE TEST WITH THE SAME RESULT. NO VALUES COULD BE OBTAINED DUE TO THE MOTOR STALL. ANOTHER INSTRUMENT WAS USED TO OBTAIN ALL QUALITY CONTROL RESULTS. THE LOT NUMBER OF THE CARTRIDGES USED COULD NOT BE PROVIDED. 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. 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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE REPORTED INSTRUMENT FAILED QUALITY CONTROLS WAS VERIFIED DURING SERVICE. THE SERVICE TECHNICIAN SPOKE WITH THE CUSTOMER AND THEY STATED THE INSTRUMENT WOULD PASS THE HEPTRAC BUT NOT LIQUID QC'S. THE ISSUE WAS RESOLVED BY REPLACING THE PCBA DECTECTOR AND ASSY, PHOTOTRANSISTOR BD. PREVENTATIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. THE INSTRUMENT WAS SERVICED/ANALYZED IN THE FACILITY BY A FIELD SERVICE TECHNICIAN. THE INSTRUMENT DID NOT RETURN TO A MEDTRONIC FACILITY FOR SERVICE/ANALYSIS. ADDITIONAL INFORMATION H6.2 EVAL CODE METHOD (FDM/ANNEX B): THIS FIELD WAS UPDATED. ADDITIONAL INFORMATION H6.3 EVAL CODE RESULT (FDR/ANNEX C): THIS FIELD WAS UPDATED. 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 INSTRUMENT FAILED QUALITY CONTROLS. 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
    29579 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown