BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT PLUS INSTRUMENT

    MDR report key: 12710685 · Received October 28, 2021

    Report

    Report Number
    2184009-2021-00101
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    September 29, 2021
    Report Date
    January 21, 2022
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    GKN
    PMA / PMN Number
    K940426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS AND INVESTIGATION: THE REPORTED 12% CHANNEL VARIANCE ISSUE WAS NOT VERIFIED DURING SERVICE. TECHNICIAN WAS NOT ABLE TO CONFIRM THE SPREAD ERROR, HOWEVER THE LIFT WIRE HAD A LOT OF BLOOD ON IT AND IT WAS SET TOO LOW (.0830, SPEC. .0920+/- .004). THIS ISSUE WAS RESOLVED BY SETTING LIFT WIRE HEIGHT TO .0915. DURING SERVICE, TECHNICIAN FOUND THE FRONT CASE IS BROKEN AND THE DEVICE DOESN'T KEEP THE DATE OR TIME PROPERLY. THIS ISSUE WAS RESOLVED BY REPLACING THE OVERLAY KEYPAD (86574), OVERLAY SOFTKEY (86575), ASSY SWITCH KYPAD (M961239A001), ASSY SWITCH SFTKY (M961240A001), KEYPAD PLATE (M953607A001) AND HOUSING FRONT (71605). THE SUBASSY SBC (M930227A002) WAS REPLACED TO RESOLVE DATE/TIME ISSUE. PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATION. NO PATIENT/CLINICAL SAFETY ISSUES REPORTED. TRENDS FOR ISSUES WITH THIS PRODUCT ARE REVIEWED AT QUARTERLY QUALITY MEETINGS. 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 · 1

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

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS ACT PLUS INSTRUMENT THE CUSTOMER WAS GETTING GREATER THAN 12% CHANNEL VARIANCE DURING QUALITY CONTROLS AND PATIENT TESTING. THE CUSTOMER TRIED DIFFERENT CARTRIDGES AND OPERATORS WITH THE SAME RESULT. THE CUSTOMER COMPARED THE RESULTS SIDE BY SIDE TO ANOTHER ACT PLUS INSTRUMENT AND IT PASSED ON THE OTHER INSTRUMENT, BUT THIS ONE (SERIAL NUMBER (B)(4)) DID NOT. THE CUSTOMER RAN ELECTRONIC QUALITY CONTROLS (EQC) AT ALL SETTINGS AND IT PASSED SEVERAL TIMES. THE INSTRUMENT WAS CHANGED OUT WITH A BACKUP AND THERE WAS NO RESULTING ADVERSE PATIENT EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607087 ACT PLUS INSTRUMENT TIMER, CLOT, AUTOMATED GKN PERFUSION SYSTEMS ACT100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown