BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 21344457 · Received February 10, 2025

    Report

    Report Number
    2184009-2025-00120
    Event Type
    Malfunction
    Date Received
    February 10, 2025
    Date of Event
    February 5, 2025
    Report Date
    February 17, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    UDI-DI
    00763000158002
    PMA / PMN Number
    K111339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LOT NUMBER OF THE USED CARTRIDGES COULD NOT BE PROVIDED BY THE CUSTOMER, BUT THEY DID NOT EXPERIENCE ANY ISSUES WITH THE SAME LOT NUMBERS. THE INSTRUMENT PASSED THE HEPTRAC (ELECTRONIC CONTROLS) AND QUALITY CONTROLS ARE PERFORMED DAILY. 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, AN ERROR MESSAGE "HPT TEST GREATER THAN 249 SECONDS" WAS ENCOUNTERED WHEN RUNNING A TEST ON THE HMS PLUS INSTRUMENT. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SERVICE TEAM SPOKE TO THE CUSTOMER VIA PHONE AND THEY INFORMED THAT AFTER THE HTC TEST RETURNED TO WHAT THEY DETERMINED TO BE A NORMAL LEVEL, THEY SAID THE ERROR WENT AWAY. THIS WAS THE FIRST TIME THEY HAD THIS ISSUE WITH THIS INSTRUMENT AND THEY DECIDED TO DECLINE SERVICE AT THIS TIME. NO FURTHER ACTION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1754032 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514 00763000158002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown