BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 19824824 · Received July 25, 2024

    Report

    Report Number
    2184009-2024-00433
    Event Type
    Malfunction
    Date Received
    July 25, 2024
    Date of Event
    June 27, 2024
    Report Date
    August 1, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    PMA / PMN Number
    K101271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THERE WERE ERRORS DURING QUALITY CONTROL (QC). THE MOTOR ALSO SOUNDED LIKE IT WAS STICKING. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. CORRECTION TO THE ADDITIONAL CODES SECTION: UPDATED THE FDP AND IMF (ANNEX F) CODES. 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 ERRORS WITH QUALITY CONTROL (QC) AND THE MOTOR STICKING WERE VERIFIED DURING SERVICE. DURING THE DROP TEST THE SERVICE TECHNICIAN FOUND THAT TRACK 1 WAS AT 65. THE ISSUE WAS RESOLVED BY ADJUSTING AND CLEANING THE WORM GEARS AND RETESTING THE INSTRUMENT. THE INSTRUMENT PASSED THE RETESTING AND IT FUNCTIONED AS INTENDED. POST REPAIR TESTING WAS PERFORMED PER SPECIFICATIONS. NOTE: THE INSTRUMENT WAS ANALYZED/SERVICED IN THE FACILITY BY A FIELD SERVICE TECHNICIAN THE INSTRUMENT DID NOT RETURN TO A MEDTRONIC FACILITY FOR ANALYSIS/SERVICE. 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, THE CUSTOMER REPORTED ERRORS WITH QUALITY CONTROL (QC). THE CUSTOMER STATED THAT THE MOTOR SOUNDED LIKE IT WAS STICKING. THE USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365238 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown