BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT PLUS INSTRUMENT

    MDR report key: 14630258 · Received June 8, 2022

    Report

    Report Number
    2184009-2022-00131
    Event Type
    Malfunction
    Date Received
    June 8, 2022
    Date of Event
    May 9, 2022
    Report Date
    July 12, 2022
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    GKN
    PMA / PMN Number
    K940426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS: THE REPORTED FAULTY/ UNTRUSTED VALUES ISSUE VERIFIED DURING SERVICE. THE TECHNICIAN FOUND THE TUBE MANAGEMENT BLOCKED, ALONG WITH UP AND DOWN KEYBOARD NOT WORKING. THE INSTRUMENT WAS COMPLETELY DIRTY AS MAINTENANCE HAD NOT BEEN PERFORMED SINCE 2009. THE ANODIZED BLOCK HAD AN OBSTRUCTION IN THE RIGHT TUBE COMPARTMENT. THE DIRTY ANODIZED BLOCK INSIDE THE TUBE COMPARTMENT ITSELF DID NOT ALLOW A EASY SLIDING OF THE PISTONS ON THE Y AXIS. TECHNICIAN ALSO IDENTIFIED BOTTOM KEYBOARD FAULT, UPPER KEYBOARD FAULT AND BOTH DISPLAYS FAULT WORN FLAT CABLES. THE UPPER DISPLAY (VALUES) WHICH HAD THE FLAT CONNECTOR BROKEN WAS NOT THE REASON FOR THE UNRELIABLE VALUES. THE DISPLAY BOARD CONNECTOR CAUSED THE PROBLEM OF THE UPPER AND LOWER KEYBOARD MALFUNCTION. THE ISSUE WAS RESOLVED BY REPLACING THE DISPLAY, CABLE RIBBON DISPLAY, KEYPAD OVERLAY INTL, PCB ASSY DISPLAY, ASSY SWITCH SOFTKEY, ASSY SWITCH KEYPAD, CABLE FLEX DISPLAY AND OVERLAY SOFTKEY. PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. DEVICE AVAILABLE FOR EVALUATION:: 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

    CONCLUSION: AFTER INVESTIGATION, THE COMPLAINT IS CONFIRMED FOR THE ACT PLUS INSTRUMENT¿S REPORTED FAULT AND UNTRUSTED VALUES. THE ISSUE WAS VERIFIED DURING SERVICE WHEN THE TECHNICIAN FOUND THE TUBE MANAGEMENT WELL BLOCKED, ALONG WITH THE UP AND DOWN KEYBOARD NOT WORKING. THE INSTRUMENT WAS COMPLETELY DIRTY AS MAINTENANCE HAD NOT BEEN PERFORMED SINCE 2009. THE ANODIZED BLOCK HAD AN OBSTRUCTION IN THE RIGHT TUBE COMPARTMENT. THE DIRTY ANODIZED BLOCK INSIDE THE TUBE COMPARTMENT ITSELF DID NOT ALLOW AN EASY SLIDING OF THE PISTONS ON THE Y AXIS. THE TECHNICIAN ALSO IDENTIFIED A BOTTOM KEYBOARD FAULT, AN UPPER KEYBOARD FAULT AND BOTH DISPLAYS HAD FAULTY WORN FLAT CABLES. THE UPPER DISPLAY (VALUES) WHICH HAD THE FLAT CONNECTOR BROKEN WAS NOT THE REASON FOR THE UNRELIABLE VALUES. THE DISPLAY BOARD CONNECTOR CAUSED THE PROBLEM OF THE UPPER AND LOWER KEYBOARD MALFUNCTION. THE ISSUE WAS RESOLVED BY REPLACING THE DISPLAY, CABLE RIBBON DISPLAY, KEYPAD OVERLAY, PCB ASSY DISPLAY, ASSY SWITCH SOFTKEY, ASSY SWITCH KEYPAD, CABLE FLEX DISPLAY, AND OVERLAY SOFTKEY. 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. 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 PRIOR TO USE OF THIS ACT PLUS INSTRUMENT HAD A FAULT AND UNTRUSTED VALUES. THE INSTRUMENT WAS RE PLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT IT IS UNKNOWN HOW OFTEN IS QUALITY CONTROL PERFORMED FOR THIS INSTRUMENT BUT THE PREVENTATIVE MAINTENANCE WAS NOT PERFORMED ON THE INSTRUMENT SINCE 2009. NO ERROR CODES WERE FOUND ASSOCIATED WITH THIS ISSUE, IN THE STATICS LOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2159818 ACT PLUS INSTRUMENT TIMER, CLOT, AUTOMATED GKN PERFUSION SYSTEMS ACT200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown