BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLOG IQ

    MDR report key: 23508625 · Received November 10, 2025

    Report

    Report Number
    2184009-2025-01436
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    November 5, 2025
    Report Date
    November 28, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    CAC
    UDI-DI
    00643169982864
    PMA / PMN Number
    K181954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE REPORTED BLOOD INTO THE WASTE BAG ISSUE WAS VERIFIED DURING SERVICE. THE SERVICE TECHNICIAN OBSERVED THAT THE OPTICS WERE DIRTY, AND CLEANED DRIED BLOOD AND DEBRIS. LED 10 WAS INITIALLY UNRESPONSIVE, AND THE LED GAIN WAS AT 107% AND LED CURRENT WAS 41MA. THE CUSTOMER ALSO REPORTED VACUUM FAILURE. THE HISTORY ERROR LOG RECORDED VACUUM SYSTEM 032 036. THESE ISSUES WERE RESOLVED BY READJUSTING AND CALIBRATED THE EMITTER AND DETECTOR GAIN TO 40MA% AND 100% ON THE SYSTEM CONTROLLER PCBA BOARD. THE SERVICE TECHNICIAN FLUSHED THE DRIED BLOOD FROM THE VACUUM SYSTEM, AND REPLACED THE FLUID TRAP. PREVENTIVE MAINTENANCE WAS PERFORMED AS PER SPECIFICATION. NOTE: THE INSTRUMENT WAS SERVICED/ANALYZED IN THE FACILITY BY A FIELD SERVICE TECHNICIAN. THE INSTRUMENT DID NOT RETURN TO A MEDTRONIC FACILITY FOR SERVICE/ANALYSIS. ADDITIONAL INFORMATION B5. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT IT IS UNKNOWN THE AMOUNT OF BLOOD LOSS AND WHETHER A TRANSFUSION WAS REQUIRED DUE TO THE REPORTED ISSUE. 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

    ADDITIONAL INFORMATION H6.4 EVAL CODE CONCLUSION (FDC/ANNEX D): THIS FIELD WAS 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

    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 AT AN UNSPECIFIED TIME, THIS AUTOLOG IQ INSTRUMENT WAS NOT SAVING BLOOD AND WAS LETTING IT ALL SPILL INTO THE WASTE BAG.THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170913 AUTOLOG IQ APPARATUS, AUTOTRANSFUSION CAC PERFUSION SYSTEMS ATLGIQ 00643169982864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown