BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 14186576 · Received April 22, 2022

    Report

    Report Number
    2184009-2022-00090
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 24, 2021
    Report Date
    June 29, 2022
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    UDI-DI
    00673978698793
    PMA / PMN Number
    K101271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED TO MEDTRONIC VIA HMS CLINICAL SPECIALIST - THERE ARE MANY FACTORS THAT AFFECT THE END RESULT. HOW CLOSE WE ARE TO THE MEAN IS NOT A RELEVANT STATISTIC, ONLY WHETHER WE ARE WITHIN THE ACCEPTABLE RANGE. CONTROLS TESTING DURING MANUFACTURING IS DONE WITH VARIOUS AGES OF CARTRIDGES. NOTE, TERM ¿NORMAL¿ HERE REFERS TO CONTROL SAMPLE MIMICKING NON-HEPARINIZED SAMPLE AND ¿ABNORMAL¿ TO CONTROL SAMPLE MIMICKING HEPARINIZED SAMPLE. LABS WILL ROUTINELY LOG THEIR CONTROLS TESTING RESULTS. (THIS IS NOT PER MEDTRONIC INSTRUCTIONS.) THIS WAS AN INQUIRY REGARDING THE DATA THE CUSTOMER COLLECTED AND THE CALCULATIONS. THERE IS NO ISSUE WITH THE HMS PLUS INSTRUMENT AND EVENT WILL BE TREATED AS A NON COMPLAINT AS IT DOES NOT MEET THE DEFINITION OF A COMPLAINT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION STATING THAT THE ISSUE THE CUSTOMER NEEDS TO RESOLVE IS WITH THEIR CAP PROFICIENCY SURVEY. ALTHOUGH ALL THE RESULTS WERE ACCEPTABLE, THE GRAPH SHOWS A PRONOUNCED POSITIVE BIAS FOR THE LAST THREE SURVEYS. THE CUSTOMER REVIEWED THE LIQUID QUALITY CONTROL RESULTS FOR THIS YEAR FOR ALL OF THEIR HMS PLUS INSTRUMENTS AND THEY ARE ALL WITHIN RANGE, BUT THE ¿NORMAL¿ LEVEL RUNS ABOVE THE MEAN WHILE THE ¿ABNORMAL¿ LEVEL RUNS BELOW THE MEAN. CORRECTION H.7.8: UPDATED TO REUSE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING QUALITY CONTROL TESTING ON THIS HMS PLUS INSTRUMENT, THE CUSTOMER IS REPORTING SOME TRENDS. THE ACCOUNT HAS BEEN PERFORMING THE LIQUID QC¿S ONCE A WEEK. THE LEVEL 1¿S RUN ABOVE THE MEAN AND THE LEVEL 2¿S RUN BELOW. THIS IS CONSISTENT ON ALL 3 ANALYZERS. CUSTOMER IS NOT SURE IF THIS IS DUE TO OPERATOR ERROR OR INSTRUMENT ERROR. CONTROL CARTRIDGES BEING USED WITH THE INSTRUMENTS ARE - CONTROL LEVEL 1 - 0013384830, CONTROL LEVEL 2 - 0013386314.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274447 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514 00673978698793

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown