BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 19787230 · Received July 20, 2024

    Report

    Report Number
    2184009-2024-00415
    Event Type
    Malfunction
    Date Received
    July 20, 2024
    Date of Event
    June 24, 2024
    Report Date
    July 20, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    UDI-DI
    00673978698793
    PMA / PMN Number
    K101271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE UNIT'S ABNORMAL CONTROLS WERE NOT PASSING. THE INSTRUMENT WAS USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER RE-RAN CONTROLS AND IT PASSED WITHOUT A PROBLEM. THE UNIT HAS BEEN FUNCTIONING WITHOUT ERROR. CUSTOMER NOT REQUESTING REPAIR. NO FURTHER ACTION REQUIRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE LOT NUMBERS OF CONTROL CARTRIDGES USED WAS 0228218017/EXP. DATE 09/05/2024 AND IN USE SINCE MAY 2024. LIQUID QUALITY CONTROLS WERE USED AND HEPTRAC PASSED WITH NO PROBLEMS. QUALITY CONTROL ARE PERFORMED ONCE A WEEK FOR LIQUID QUALITY CONTROLS AND EVERY 8 HOURS OF PATIENT TESTING FOR THE ELECTRONIC CONTROL. THERE WAS NO ERROR CODE ASSOCIATED WITH THIS ISSUE. THE VALUES OBTAINED WERE 324, 324, 321 AND 311 WHICH WERE OUTSIDE OF THE ACCEPTABLE RANGES (335-627).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1501105 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514 00673978698793

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown