BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 21642089 · Received March 19, 2025

    Report

    Report Number
    2184009-2025-00433
    Event Type
    Malfunction
    Date Received
    March 19, 2025
    Date of Event
    February 21, 2025
    Report Date
    March 19, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    UDI-DI
    00763000158002
    PMA / PMN Number
    K111339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE REPORTED REPEATED ABNORMAL QUALITY CONTROL (QC) FAILED RESULTS WAS NOT VERIFIED DURING SERVICE. THE UNIT PASSED ALL PREVENTIVE MAINTENANCE TESTS WITHOUT ERROR AND NO PROBLEM WAS FOUND. THE SERVICE TECHNICIAN REQUESTED THE CLINICAL SPECIALIST TO CALL THE CUSTOMER TO ANSWER QUESTIONS ABOUT QUALITY CONTROL PROCEDURES. PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. NOTE: THE INSTRUMENT WAS SERVICED IN THE FIELD BY A MEDTRONIC FIELD SERVICE TECHNICIAN. THE INSTRUMENT WAS NOT RETURNED TO A MEDTRONIC FACILITY. 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 AT AN UNSPECIFIED TIME, THIS HMS PLUS INSTRUMENT HAD A REPEATED ABNORMAL QUALITY CONTROL (QC) FAILED RESULTS. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LOT NUMBER OF THE CARTRIDGES WAS 0229862883. THE ISSUE WAS WITH FAILED LIQUID QC FOR ACT. ABNORMAL QC WAS RUN MANY TIMES WHICH FAILED REPEATEDLY. LIQUID ACT QC IS DONE ONCE A WEEK BY THE CUSTOMER, ELECTRONIC QC IS DONE DAILY. THERE WAS NO ERROR CODE ASSOCIATED WITH THIS ISSUE OBSERVED. IT WAS REPORTED THAT THE ACT QC RESULTS ARE USED TO VALIDATE THE INSTRUMENT, SO VALUES WERE NOT USED IN A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546439 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514 00763000158002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown