BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 21616612 · Received March 17, 2025

    Report

    Report Number
    2184009-2025-00427
    Event Type
    Malfunction
    Date Received
    March 17, 2025
    Date of Event
    March 11, 2025
    Report Date
    April 9, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    UDI-DI
    00673978698793
    PMA / PMN Number
    K111339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.5.MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT QUALITY LIQUIDS CONTROLS ARE PERFORMED WEEKLY. NO ERROR CODES WERE DISPLAYED DUE TO THE REPORTED ISSUE AND NO CONTROL VALUES WERE OBTAINED, THEREFORE THEY WERE NOT USED IN THE CASE. DEVICE EVALUATION:THE REPORTED ISSUE THAT THERE WAS INCREASED DIFFICULTY IN GETTING LIQUID ACT ABNORMALS TO PASS TESTS, AND CLOT DETECTION OCCURRED SLIGHTLY EARLY OF THE PRESCRIBED RANGE WAS VERIFIED DURING SERVICE. THE SERVICE TECHNICIAN CONFIRMED THAT THE INSTRUMENT PERFORMED WITHIN MANUFACTURE SPECIFICATIONS AND STILL FAILED ABNORMAL CONTROLS WITH ACT CARTRIDGES. THE CUSTOMER DECIDED TO TRY DIFFERENT LOTS OF CARTRIDGES BEFORE PROCEEDING TO SERVICE/REPAIR. NOTE: 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

    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

    IT WAS REPORTED THAT PRIOR TO USE THIS HMS PLUS INSTRUMENT, THERE WAS INCREASED DIFFICULTY IN GETTING LIQUID ACT ABNORMALS TO PASS TESTS, AND CLOT DETECTION OCCURRED SLIGHTLY EARLY OF THE PRESCRIBED RANGE. ALL OTHER LIQUID CONTROLS PASSED WITHIN THE ACCEPTABLE RANGES. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15240 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514 00673978698793

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown