BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 21414344 · Received February 19, 2025

    Report

    Report Number
    2184009-2025-00279
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    February 17, 2025
    Report Date
    April 1, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    UDI-DI
    00763000158002
    PMA / PMN Number
    K111339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.5.MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT MEDTRONIC SERVICE ARRIVED AT THE SITE AND TRIED TO CONTACT CUSTOMER WITH NO RESPONSE. FOUND THE LAB AND WAS INFORMED THAT THE ISSUE WAS FIXED AND RETURNED IT TO THE OPERATING ROOM. NO FURTHER ACTION REQUIRED.MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER TESTED THE UNIT AND COULD NOT FIND ANY ISSUES WITH IT. SERVICE CLOSED THE CASE BASED ON THE CUSTOMER¿S FINDINGS. NO FURTHER ACTION REQUIRED 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 PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE LIQUID QUALITY CONTROL WOULD NOT PASS AND IT WAS NOT DISPENSING THE SAME AMOUNT IN EACH CHANNEL (5 AND 6). THE INSTRUMENT WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59586 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514 00763000158002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown