BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 22060556 · Received May 21, 2025

    Report

    Report Number
    2184009-2025-00677
    Event Type
    Malfunction
    Date Received
    May 21, 2025
    Date of Event
    May 17, 2025
    Report Date
    July 29, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    UDI-DI
    00673978698793
    PMA / PMN Number
    K101271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE REPORTED ABNORMAL QC FAIL ISSUE WAS VERIFIED DURING SERVICE. SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE ISSUE. THE LIFT WIRE HEIGHT AND FLAG DROP TIMES WERE ADJUSTED. HOWEVER, AFTER ADJUSTMENTS, THE ABNORMAL QC WOULD GIVE AN INTERMITTENT PASS AND FAIL. AND EACH TIME THE NUMBERS WERE COMING IN TOO LOW. UNIT WILL BE FORWARDED TO THE CLINICAL SPECIALIST FOR FURTHER DIRECTION. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    B.5.MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT BOTH LIQUID AND ELECTRONIC CONTROLS WERE USED, AND QUALITY CONTROL QC IS PERFORMED FOR THIS UNIT ONCE PER WEEK. NO ERROR CODES FOUND, ONLY INTERMITTENT FAILING AND PASSING WHEN RUNNING ABNORMAL CONTROLS. THE PROBLEM IS THE CONTROLS. THE RESULTS WERE OUT OF RANGE SPECIFIED BY THE REQUIRED SPECIFICATIONS. DEVICE EVALUATION UPDATED INFORMATION:THE REPORTED ABNORMAL QUALITY CONTROL(QC) FAIL ISSUE WAS VERIFIED DURING SERVICE. SERVICE CAME TO THE SAME CONSENSUS AS THE BIOMED AND THE REST OF THE PERFUSION STAFF CONCERNING THE REPORTED ISSUE OF ABNORMAL CONTROLS INTERMITTENTLY PASSING AND FAILING ON ALL HMS PLUS UNITS. SERVICE RAN MULTIPLE ROUNDS OF ABNORMAL QUALITY CONTROLS (QC¿S) ON ALL UNITS (EXCEPT THE OPERATING ROOM 4 UNIT ). SERVICE SPOKE WITH THE BIOMED IN PERFUSION.A WEEK AGO APPROXIMATELY, SERVICE SENT THE CUSTOMER A DIFFERENT LOT OF ABNORMAL CONTROLS THINKING THAT MIGHT RESOLVE THE ISSUE, BUT IT WAS ONLY TEMPORARILY WHICH IS WHY SERVICE ENDED UP COMING ON SITE AND BROUGHT A SEPARATE SET OF ABNORMAL CONTROLS TO RUN. SERVICE BROUGHT LOT# 231185771 (EXP2025-11-26) AND THE FIRST ROUND ON ALL UNITS PASSED. THE SECOND-ROUND UNITS BEGAN TO INTERMITTENTLY PASS/ FAIL SOMETIMES. CUSTOMER WAS EXPERIENCING THE SAME ISSUES WHEN RUNNING LOT# 231145260 AND LOT#230878041. SERVICE TECHNICIAN WAS ABLE TO DUPLICATE THE ISSUE. THE LIFT WIRE HEIGHT AND FLAG DROP TIMES WERE ADJUSTED. HOWEVER AFTER ADJUSTMENTS, THE ABNORMAL QUALITY CONTROL (QC) WOULD GIVE AN INTERMITTENT PASS AND FAIL. AND EACH TIME THE NUMBERS WERE COMING IN TOO LOW. UNIT WILL BE FORWARDED TO THE CLINICAL SPECIALIST FOR FURTHER DIRECTION. 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

    ADDITIONAL INFORMATION B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THIS ISSUE OF FAILING QC HAS IMPROVED WITH STAFF TECHNIQUE TRAINING BUT IT HAS NOT PERMANENTLY SOLVED THE ISSUE. THE CUSTOMER STILL HAS RANDOMLY FAILING QC TESTING BUT THEN WHEN THEY RE-RUNS IT, IT PASSES. CORRECTION D4.5 (UNIQUE IDENTIFIER (UDI) #): THIS FIELD HAS BEEN UPDATED. CORRECTION ADDITIONAL CODES (IMF (ANNEX F) HEALTH IMPACT): THIS CODE 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A HMS PLUS INSTRUMENT, IT WAS REPORTED THAT THE UNIT HAD AN INTERMITTENT ABNORMAL QUALITY CONTROL FAILURE. THE INSTRUMENT WAS USED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937126 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514 00673978698793

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown