BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT PLUS INSTRUMENT

    MDR report key: 19791236 · Received July 22, 2024

    Report

    Report Number
    2184009-2024-00413
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 12, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    GKN
    UDI-DI
    00643169178380
    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

    DEVICE EVALUATION SUMMARY: THE REPORTED ISSUE THAT RESULTS ON THIS MACHINE WERE USUALLY MUCH LOWER COMPARED TO ANOTHER UNIT WAS NOT VERIFIED DURING SERVICE. THE SERVICE TECHNICIAN FOUND UNIT PASSING ELECTRONIC QUALITY CONTROLS AT 100, 200 AND 500 SECONDS WITHOUT PROBLEMS. INSPECTED INTERIOR OF UNIT, NO PROBLEM FOUND. UNIT PASSED ALL CHECKS WITHOUT ERROR. THE SERVICE TECHNICIAN REPLACED THE FLAG SENSOR PCB AS PRECAUTION. PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE INSTRUMENT PASSED QUALITY CONTROLS WITHOUT ISSUE. THE PROBLEM AROSE WHEN USED ON AN ACTUAL PATIENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT ELECTRONIC CONTROL WAS PERFORMED EVERY 8 HOURS AND LIQUID CONTROLS ARE PERFORMED ONCE A WEEK. NO ERROR CODE WAS DISPLAYED WHEN THIS ISSUE OCCURRED. THE CONTROL VALUES WERE NOT USED IN THE PROCEDURE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THE ACT MACHINE PASSED BOTH QUALITY CONTROLS (QC), ELECTRONIC AND WET QC, HOWEVER WHEN COMPARED RESULTS WITH THE 2N ACT MACHINE IN THE DEPARTMENT, THE RESULTS ON THIS MACHINE WERE USUALLY MUCH LOWER. THE OTHER MACHINE HAD RESULTS THAT WERE MORE CREDIBLE FOR THE AMOUNT OF HEPARIN GIVEN. THE INSTRUMENT WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737431 ACT PLUS INSTRUMENT TIMER, CLOT, AUTOMATED GKN PERFUSION SYSTEMS ACT100 00643169178380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown