BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 21089523 · Received January 7, 2025

    Report

    Report Number
    2184009-2025-00008
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    December 26, 2024
    Report Date
    January 23, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    PMA / PMN Number
    K111339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION H^: UPDATED THE ANNEX D CODE 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 ISSUE THAT THE INSTRUMENT FAILED ITS CONTROLS MULTIPLE TIMES WAS VERIFIED. END USERS TECHNIQUE WHEN RUNNING ABNORMAL CONTROLS WAS ADDRESSED AND CUSTOMER WAS INSTRUCTED ON HOW TO RUN WET CONTROLS IN A DIFFERENT WAY BY LETTING THE CONTROLS RECONSTITUTION PERIOD BE EXTENDED. CUSTOMER DEVICE IS NOW PASSING ABNORMAL CONTROLS. NOTE THAT THE INSTRUMENT WAS NOT RETURNED TO MEDTRONIC FACILITY. THE SERVICE TECHNICIAN WAS ABLE TO RESOLVE THE ISSUE VIA PHONE. 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. 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 ITS CONTROLS MULTIPLE TIMES. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE INSTRUMENT FAILED THE ABNORMAL CONTROLS (LIQUID CONTROLS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1010929 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown