BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLOG IQ

    MDR report key: 22528586 · Received July 17, 2025

    Report

    Report Number
    2184009-2025-00857
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    June 18, 2025
    Report Date
    August 14, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    CAC
    PMA / PMN Number
    K181954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT NO DAMAGE WAS NOTED TO THE INSTRUMENT, AND NO VISUAL, AUDIBLE, OR PERFORMANCE ABNORMALITIES WERE OBSERVED. THE LEAK OCCURRED IN THE CENTRIFUGE, AND THE TUBING DID NOT NEED TO BE RECONNECTED. NO ERROR OR WARNING MESSAGES WERE DISPLAYED. IT IS NOT KNOWN WHETHER A BLOOD TRANSFUSION WAS REQUIRED DUE TO THE REPORTED LEAK. CORRECTION H4 (DEVICE MFG DATE): THIS FIELD HAS BEEN UPDATED. 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

    DEVICE EVALUATION SUMMARY: THE REPORTED ISSUE OF THE INSTRUMENT NOT OPERATING CORRECTLY, AND NOT SAVING ENOUGH CELLS WAS NOT VERIFIED DURING SERVICE. THE SERVICE TECHNICIAN PERFORMED THE HIGH LEVEL TEST (HLT) WITH NO ISSUES. THE INSTRUMENT WAS PUT BACK IN SERVICE. NO FURTHER ISSUES AT THIS TIME. POST-REPAIR TESTING WAS PERFORMED PER SPECIFICATIONS. NOTE: THE INSTRUMENT WAS NOT RETURNED TO A MEDTRONIC FACILITY FOR SERVICE/ANALYSIS. THE INSTRUMENT WAS SERVICED IN THE FACILITY BY A FIELD SERVICE ENGINEER. 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 INSTRUMENT WAS NOT OPERATING CO RRECTLY, AND IT WAS NOT SAVING ENOUGH CELLS. THE PATIENT LOST OVER 2000MG, AND THE INSTRUMENT ONLY SAVED 250 RED BLOOD CELLS. THE WASH AND WASTE BAGS WERE BOTH DARK RED. 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
    615785 AUTOLOG IQ APPARATUS, AUTOTRANSFUSION CAC PERFUSION SYSTEMS ATLGIQ

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown