BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT PLUS INSTRUMENT

    MDR report key: 14434926 · Received May 19, 2022

    Report

    Report Number
    2184009-2022-00108
    Event Type
    Malfunction
    Date Received
    May 19, 2022
    Date of Event
    April 21, 2022
    Report Date
    June 21, 2022
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    GKN
    UDI-DI
    00721902793066
    PMA / PMN Number
    K940426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: THE INSTRUMENT WAS ANALYZED DURING FIELD SERVICE AT THE FACILITY. THE REPORTED ISSUE WITH THE TEMPERATURE FLUCTUATIONS AND NOT PASSING LIQUID QUALITY WERE VERIFIED DURING FIELD SERVICE. THE ISSUE WAS RESOLVED BY REPLACING THE HEAT BLOCK ASSEMBLY. UPON INSTALLATION OF THE HEAT BLOCK, THE TECHNICIAN ADJUSTED THE TEMPERATURE PER THE SERVICE MANUAL TO 37.0 DEGREES CELSIUS. THE TECHNICIAN OBSERVED THAT THE HEAT BLOCK TEMPERATURE WAS CONSISTENT AT 37 DEGREES. THE TECHNICIAN RAN ELECTRONIC QUALITY CONTROLS (EQC) ON THE INSTRUMENT 10 TIMES WITHOUT ERROR. PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. 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

    B5 ADDITIONAL INFORMATION: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE INSTRUMENT FAILED LIQUID QUALITY CONTROLS DUE TO THE FLUCTUATION OF TEMPERATURE FROM THE HEAT BLOCK. CONCLUSION: THE COMPLAINT IS CONFIRMED FOR THE ACT PLUS INSTRUMENT¿S REPORTED TEMPERATURE FLUCTUATION. THE ISSUE WAS VERIFIED DURING SERVICE AND WAS RESOLVED BY REPLACING THE HEAT BLOCK ASSEMBLY. UPON INSTALLATION OF THE HEAT BLOCK, THE TECHNICIAN ADJUSTED THE TEMPERATURE PER THE SERVICE MANUAL TO 37.0 DEGREES CELSIUS. THE TECHNICIAN OBSERVED THAT THE HEAT BLOCK TEMPERATURE WAS CONSISTENT AT 37 DEGREES CELSIUS. THE TECHNICIAN RAN ELECTRONIC QUALITY CONTROLS (EQC) ON THE INSTRUMENT 10 TIMES WITHOUT ERROR. NO PATIENT/CLINICAL SAFETY ISSUES WERE REPORTED. TRENDS FOR ISSUES WITH THIS INSTRUMENT ARE MONITORED. 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. 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 PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT A TEMPERATURE FLUCTUATION OCCURRED. THE TEMPERATURE WAS FLUCTUATING FORM FROM 36 TO 44 DEGREES CELSIUS. THE INSTRUMENT FAILED LIQUID QUALITY CONTROLS THREE TIMES CONSECUTIVELY. 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
    2094478 ACT PLUS INSTRUMENT TIMER, CLOT, AUTOMATED GKN PERFUSION SYSTEMS ACT100 00721902793066

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown