BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLOG IQ

    MDR report key: 19545872 · Received June 17, 2024

    Report

    Report Number
    2184009-2024-00363
    Event Type
    Malfunction
    Date Received
    June 17, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 22, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    CAC
    UDI-DI
    00643169982864
    PMA / PMN Number
    K181954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION:THE REPORTED ISSUE WAS VERIFIED DURING SERVICE. THE SERVICE TECHNICIAN OBSERVED THE INSTRUMENT TO BE CLEAN AND FREE OF DEBRIS. THE SERVICE TECHNICIAN MEASURED THE OPTICS VOLTAGES WHICH WERE LOW AND THEREFORE WOULD CREATE THE REPORTED ISSUE. THE SERVICE TECHNICIAN CLEANED THE OPTICS WITHIN THE CENTRIFUGE. THE SERVICE TECHNICIAN CALIBRATED THE OPTICS 40 <(>&<)> 100 AMPS PER SPECIFICATIONS AND TESTED FOR ANY DRIFTING. THE SERVICE TECHNICIAN CONFIRMED THAT THE VOLTAGES WERE SOLID AND COMPLETED THE HIGH LEVEL TEST (HLT). PREVENTIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. NOTE:INSTRUMENT WAS SERVICED AT THE FACILITY BY MEDTRONIC FIELD SERVICE AND WAS NOT RETURNED TO MEDTRONIC SERVICE CENTER. 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

    UPDATE TO B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER DID NOT KNOW THE AMOUNT OF BLOOD LOSS, BUT FELT IT WAS MINIMAL DUE TO THEM MANUALLY SWITCHING IT TO WASH ONCE IDENTIFIED THE ISSUE, WHICH DID NOT HAPPEN AUTOMATICALLY. ADDITIONALLY, THE CUSTOMER CAN NOT CONFIRM IF A BLOOD TRANSFUSION WAS NEEDED. 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 AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT THE BLOOD LEVEL PASSED THROUGH THE DETECTION ZONE AND SPILLED CELLS INTO THE WASTE BAG. THE CUSTOMER MANUALLY SWITCHED THE INSTRUMENT TO WASH MODE AND CONTINUED THE CASE. THE INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO NOTICEABLE DAMAGE TO THE INSTRUMENT OR THE DISPOSABLE, NEITHER ANY VISUAL, AUDIBLE OR PERFORMANCE ABNORMALITIES. NO ERROR MESSAGES WERE DISPLAYED AND THE BOWL AND THE TUBING WERE NOT RE-SEATED, REINSTALLED OR REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072363 AUTOLOG IQ APPARATUS, AUTOTRANSFUSION CAC PERFUSION SYSTEMS ATLGIQ 00643169982864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown