BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 21446424 · Received February 24, 2025

    Report

    Report Number
    2184009-2025-00293
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 19, 2025
    Report Date
    March 24, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    UDI-DI
    00763000158002
    PMA / PMN Number
    K101271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.5.MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ELECTRONIC CONTROLS WERE USED IN THE CASE (HEPTRACK). THE LOT NUMBERS OF USED CONTROL CARTRIDGES WERE 230292347 EXP 7/17/25 AND LOT 230011162 EXP 6/5/25. WET QUALITY CONTROLS ARE PERFORMED ONCE A WEEK AND ELECTRONIC CONTROLS EVERY 8 HOURS. NO ERROR CODES WERE DISPLAYED,JUST FAILING ABNORMAL QC WET CONTROLS AND CONTROL VALUES WERE NOT USED IN THE CASE.CONTROLS ARE FOR END USER DEVICE VERIFICATION. DEVICE EVALUATION:THE REPORTED ISSUE THAT ABNORMAL CONTROL CARTRIDGES FAILED THE TEST, BUT OTHER CARTRIDGES WORKED AS INTENDED. PERIODICALLY, BOTH CHANNEL WOULD GIVE READINGS, BUT SOMETIMES ONLY ONE CHANNEL WOULD GIVE A READING, THE VALUES RECEIVED WERE LOWER THAN EXPECTED WAS VERIFIED DURING SERVICE. THE SERVICE TECHNICIAN OBSERVED THAT THE LIFTWIRE HEIGHT WAS ON THE LOW SIDE OF THE SPECIFICATIONS. THE ISSUE WAS RESOLVED BY ADJUSTING THE FLAG DROP TIMES TO 60 ACROSS ALL CHANNELS AND ELECTRONIC CONTROL AND ABNORMAL CONTROL PASSED. PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. NOTE:THE INSTRUMENT WAS ANALYSED BY A FIELD SERVICE TECHNICIAN WITHIN THE FACILITY. THE INSTRUMENT DID NOT RETURN TO A MEDTRONIC FACILITY FOR ANALYSIS. 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

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT ONLY THE ABNORMAL CONTROL CARTRIDGES FAILED THE TEST, BUT OTHER CARTRIDGES WORKS AS INTENDED. PERIODICALLY, BOTH CHANNEL WOULD GIVE READINGS, BUT SOMETIMES ONLY ONE CHANNEL WOULD GIVE A READING, THE VALUES RECEIVED WERE LOWER THAN EXPECTED. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404941 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514 00763000158002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown