BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT PLUS INSTRUMENT

    MDR report key: 14020499 · Received April 6, 2022

    Report

    Report Number
    2184009-2022-00066
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 14, 2022
    Report Date
    June 23, 2022
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    GKN
    UDI-DI
    00643169178410
    PMA / PMN Number
    K940426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO DEVICE EVALUATION SUMMARY: THE REPORTED ISSUE OF THE INSTRUMENT WAS BLOCKED 20 SECONDS AFTER DEPARTURE, DUE TO SOME NUMERICAL DATA DISCREPANCY WAS VERIFIED DURING SERVICE. THE FIELD SERVICE TECHNICIAN FOUND THAT THE READING VALUES WERE OUT OF RANGE. THE FIELD SERVICE TECHNICIAN OBSERVED BREAKAGE OF THE FULLY REPLACED UPGRADE KIT. THE ISSUE WAS RESOLVED BY REPLACING THE UPGRADE KIT. PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. CONCLUSION: THE COMPLAINT IS CONFIRMED. NO PATIENT/CLINICAL SAFETY ISSUES REPORTED. TRENDS FOR ISSUES WITH THIS PRODUCT 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. 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

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

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE REPORTED ISSUE OF THE INSTRUMENT WAS BLOCKED 20 SECONDS AFTER DEPARTURE, DUE TO SOME NUMERICAL DATA DISCREPANCY WAS VERIFIED DURING SERVICE. THE FIELD SERVICE TECHNICIAN FOUND THAT THE READING VALUES WERE OUT OF RANGE. THE FIELD SERVICE TECHNICIAN OBSERVED BREAKAGE OF THE FULLY REPLACED MECHANICAL PART. THE ISSUE WAS RESOLVED BY REPLACING THE UPGRADE KIT. PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. ADDITIONAL INFORMATION: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT PRIOR TO USE OF THE ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE INSTRUMENT WAS BLOCKED 20 SECONDS AFTER DEPARTURE, DUE TO SOME NUMERICAL DATA DISCREPANCY. THE INSTRUMENT WAS REPLACED WITH A BACK-UP. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE PATIENT EFFECTS OCCURRED. HEPARIN WAS NOT ADMINISTERED TO THE PATIENT BASED ON THE DATA THAT WAS RECEIVED. 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 AT AN UNSPECIFIED TIME IT WAS REPORTED THAT THIS ACT PLUS INSTRUMENT, WAS BLOCKED 20 SECONDS AFTER DEPARTURE, DUE TO SOME NUMERICAL DATA DISCREPANCY. USE OF THE INSTRUMENT WAS UNSPECIFIED AND THERE WAS NO REPORTED ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1581349 ACT PLUS INSTRUMENT TIMER, CLOT, AUTOMATED GKN PERFUSION SYSTEMS ACT200 00643169178410

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown