BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HMS PLUS INSTRUMENT

    MDR report key: 14391964 · Received May 13, 2022

    Report

    Report Number
    2184009-2022-00101
    Event Type
    Malfunction
    Date Received
    May 13, 2022
    Date of Event
    April 15, 2022
    Report Date
    August 8, 2022
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    JOX
    PMA / PMN Number
    K101271
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE REPORTED INCONSISTENT PATIENT ACTIVATED CLOTTING TIME (ACT) TEST RESULTS WHILE USING INSTRUMENT WAS VERIFIED DURING SERVICE. THE ISSUE WAS RESOLVED BY REPLACING THE SYRINGE DRIVE MOTOR AND SYRINGE TENSION SPRING. PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: COMPLAINT CONFIRMED FOR THE HMS PLUS INSTRUMENT INCONSISTENT PATIENT ACTIVATED CLOTTING TIME (ACT) TEST RESULTS. TRENDS FOR ISSUES WITH THIS PRODUCT ARE REVIEWED AT QUARTERLY QUALITY MEETINGS. THE HMS PLUS WHITE PAPER, DESCRIBES THE MOST COMMON FAILURE MODES AND THE CLINICAL IMPACT OF THESE. NO FURTHER ACTIONS TO BE TAKEN AT THIS TIME. 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 USE OF A HMS PLUS INSTRUMENT IT WAS REPORTED THAT THERE WERE INCONSISTENT PATIENT ACTIVATED CLOTTING TIME (ACT) TEST RESULTS WHILE USING DEVICE. POSSIBLE SHORT-SHOTS IN CH5 OR CH6 WHEN DISPENSING. IT WAS REPORTED THAT ERRONEOUS TEST RESULT ALWAYS OCCUR IN SHORT-SHOT CARTRIDGE CHANNEL. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE QA LAB AND PERFUSION PERFORM LIQUID QC WEEKLY AND EQC EVERY 8 HRS. NO ERROR CODES WERE REPORTED. THE CUSTOMER REFERENCED THAT ONE CHANNEL WOULD HAVE A TEST RESULT, AND OTHER CHANNEL WOULD BE 999 SEC. HEPARIN WAS NOT GIVEN BASED ON THE ERRATIC TEST RESULT. THE CUSTOMER USED A SEPARATE ACT DEVICE IN ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789249 HMS PLUS INSTRUMENT ANALYZER, HEPARIN, AUTOMATED JOX PERFUSION SYSTEMS 30514

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown