BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 20255287 · Received September 19, 2024

    Report

    Report Number
    2184009-2024-00548
    Event Type
    Malfunction
    Date Received
    September 19, 2024
    Date of Event
    September 18, 2024
    Report Date
    October 22, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    UDI-DI
    00763000158002
    PMA / PMN Number
    K111339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT A SITUATION WHERE THE 6 CHANNELS HAD DIFFERENT AMOUNTS OF BLOOD OCCURRED WITH THE HEPARIN DOSE RESPONSE (HDR) CARTRIDGES, AS WELL WITH DIFFERENT COLOR CARTRIDGES. THE LOT NUMBERS OF THE CARTRIDGES ARE UNKNOWN, BUT THIS HAPPENED WITH SEVERAL DIFFERENT LOTS. QUALITY CONTROL IS PERFORMED EVERY WEEK FOR EVERY COLOR OF CARTRIDGE. THERE WAS NO ERROR CODE, OTHER THAN THE CODE SAYING THERE WAS TOO BIG OF A GAP BETWEEN 2 HDR CHANNELS. THE DOSE OF HEPARIN WAS NOT RETAINED ON THE TESTS THAT WERE PROBLEMATIC. DEVICE EVALUATION SUMMARY: THE REPORTED ISSUE OF THE INSTRUMENT NOT GIVE GOOD RESULTS, AS IT DID NOT FILL THE CARTRIDGE TO THE RIGHT LEVEL WAS VERIFIED DURING SERVICE. NO PHYSICAL ISSUES WERE OBSERVED. THE SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE REPORTED ISSUE. THE ISSUE WAS RESOLVED BY CLEANING AND LUBRICATING ALL MOVING ASSEMBLIES AND CLEANING THE INSTRUMENT. THE INSTRUMENT WAS THEN SUCCESSFULLY POWERED ON AND IT COMPLETED THE POWER ON SELF TEST (POST) WITH NO ISSUES. THE INSTRUMENT PASSED ALL FUNCTION TESTS WITHOUT ANY ISSUES OR FAILURES. PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. CORRECTION G4.4 (PMA / 510(K) #): THIS FIELD HAS BEEN UPDATED. 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 AT AN UNSPECIFIED TIME, THIS HMS PLUS INSTRUMENT DOES NOT GIVE GOOD RESULTS, AS IT DOES NOT FILL THE CARTRIDGE TO THE RIGHT LEVEL. USE OF INSTRUMENT WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747335 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514 00763000158002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown