BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT PLUS INSTRUMENT

    MDR report key: 14547976 · Received May 31, 2022

    Report

    Report Number
    2184009-2022-00126
    Event Type
    Malfunction
    Date Received
    May 31, 2022
    Date of Event
    May 2, 2022
    Report Date
    July 1, 2022
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    GKN
    UDI-DI
    00721902793066
    PMA / PMN Number
    K940426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE REPORTED INSTRUMENT STARTED TO COUNT UP THEN WENT TO "0" AND FAILED THE TEST WAS NOT VERIFIED DURING SERVICE. THE SERVICE TECHNICIAN STATED THAT THE CUSTOMER REPORTED THAT THE INSTRUMENT ONLY HAD THE ISSUE ONCE AND SINCE THEN THE INSTRUMENT HAS WORKED FINE. THE SERVICE TECHNICIAN CHECKED THE ERROR LOG AND OBSERVED NO ERRORS. THE SERVICE TECHNICIAN CLEANED ALL THE SENSORS THOROUGHLY AND ADJUSTED THE LIFT BAR WHICH WAS ON THE LOW END OF THE THRESHOLD, RAN THE ACTTRAC 10 TIMES, ALL OF WHICH PASSED AND THE CUSTOMER RAN A SAMPLE WHICH PASSED AS WELL. POST-REPAIR TESTING WAS PERFORMED PER SPECIFICATIONS. D9: INSTRUMENT WAS SERVICED AT THE FACILITY BY MEDTRONIC FIELD SERVICE AND WAS NOT RETURNED TO MEDTRONIC SERVICE CENTRE. 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

    CORRECTION B5: ADDITIONAL INFORMATION RECEIVED FOR THIS EVENT CONFIRMED THAT THE INSTRUMENT WAS OWNED BY A MEDTRONIC LAB TEST FACILITY. AS THE INSTRUMENT WAS NOT DISTRIBUTED OUTSIDE OF MEDTRONIC, THERE WAS NO RISK OF PATIENT DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT. 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 ACT PLUS , IT WAS REPORTED THAT THE INSTRUMENT STARTED TO COUNT UP THEN WENT TO "0" AND FAILED THE TEST. THE INSTRUMENT WAS REPLACE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS ALSO RECEIVED THAT THE CUSTOMER SAID THE INSTRUMENT ONLY HAD THE ISSUE ONCE AND SINCE THEN HAS WORKED FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2684716 ACT PLUS INSTRUMENT TIMER, CLOT, AUTOMATED GKN PERFUSION SYSTEMS ACT100 00721902793066

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown