BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 14336441 · Received May 9, 2022

    Report

    Report Number
    2184009-2022-00097
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    March 29, 2022
    Report Date
    May 9, 2022
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    UDI-DI
    00763000158002
    PMA / PMN Number
    K101271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: THE REPORTED ISSUE OF LIQUID QUALITY CONTROL FAIL WAS NOT VERIFIED DURING FIELD SERVICE. THE FIELD SERVICE TECHNICIAN FOUND ERROR CODES IN THE ERROR LOG AND FOUND THE X AND Y TIMING BELTS NEEDED TO BE REPLACED. THE ISSUE WAS RESOLVED BY REPLACING THE X AND Y TIMING BELTS. PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. CONCLUSION: THE COMPLAINT WAS NOT CONFIRMED FOR THE HMS PLUS INSTRUMENT FAILING LIQUID QUALITY CONTROLS (QCS) AND FAILING "INTERNAL QCS". THE REPORTED LIQUID QC FAILURE WAS NOT VERIFIED DURING SERVICE. THE SERVICE TECHNICIAN FOUND ERROR CODES IN THE ERROR LOG AND FOUND THE X AND Y TIMING BELTS NEEDED TO BE REPLACED. THE ISSUE WAS RESOLVED BY REPLACING THE X AND Y TIMING BELTS. NO PATIENT/CLINICAL SAFETY ISSUES REPORTED. TRENDS FOR ISSUES WITH THIS INSTRUMENT ARE MONITORED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 LIQUID QUALITY CONTROLS (QC'S) AND MORE RECENTLY ALSO FAILED "INTERNAL" QC'S. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CUSTOMER WAS ASKED IF THEY MEANT ELECTRONIC QUALITY CONTROLS (EQC'S) AND THEY WERE UNSURE. THE SERVICE TECHNICIAN STATED THAT THERE WERE NO ERRORS IN THE ERROR LOG THAT PERTAINED TO THE REPORTED QC FAILS. THE SERVICE TECHNICIAN HAS NOT BEEN CONTACTED BY THE CUSTOMER POST-SERVICE REPORTING ANY FURTHER CONCERNS ABOUT THE INSTRUMENT FAILING THE QC¿S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065647 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514 00763000158002

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown