BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLOG IQ

    MDR report key: 23740011 · Received December 8, 2025

    Report

    Report Number
    2182208-2025-11618
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    November 24, 2025
    Report Date
    December 18, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    CAC
    UDI-DI
    00763000262433
    PMA / PMN Number
    K181954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION DEVICE EVALUATION SUMMARY: THE REPORTED ISSUE THAT THE INSTRUMENT WAS NOT WASHING THE BLOOD ,AND THROWING ALL THE BLOOD INTO THE DISPOSAL BAG WAS VERIFIED DURING SERVICE. THE ISSUE WILL BE RESOLVED BY REPLACING THE ASSY OPTICS LEVEL SENSOR EMITTER AUTOLOG, ASSY OPTICS LEVEL SENSOR DETECTOR, PCBA AUTOLOG SYSTEM CONTROLLER, TOP PANEL ASSEMBLY AUTOLOG AND ASSY FLUID TRAP. PREVENTATIVE MAINTENANCE WAS PERFORMED PER SPECIFICATIONS. CORRECTION D.3: MFR NAME, STREET 1, MFR CITY AND POSTAL CODE CORRECTION E.1: PHONE NUMBER 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: THE REPORTED ISSUE THAT THE INSTRUMENT WAS NOT WASHING THE BLOOD, AND THROWING ALL THE BLOOD INTO THE DISPOSAL BAG WAS VERIFIED DURING SERVICE. DURING TECHNICAL EVALUATION BY SERVICE TECHNICIAN, THE EQUIPMENT PRESENTED ERRORS 15 AND 14: FAILURE IN THE LEVEL SENSOR. HLT WAS PERFORMED, THE LEVEL SENSORS WERE CALIBRATED, AND AFTER THAT, THE EQUIPMENT PRESENTED THE ERRORS AGAIN. THE FOLLOWING ITEMS WILL BE NEEDED TO COMPLETE THE EVALUATION/REPAIR, THE ASSY OPTICS LEVEL SENSOR EMITTER AUTOLOG, ASSY OPTICS LEVEL SENSOR DETECTOR, AND PCBA AUTOLOG SYSTEM CONTROLLER. PREVENTIVE MAINTENANCE WILL BE 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

    PRODUCT ANALYSIS:MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT DISPLAY LCD RESISTIVE TOUCH PANEL GD SEP,PCBA GUI MODULE,CABLE ASSEMBLY GRAPHIC DISPLAY AND ASSY FLUID TRAP WILL ALSO BE REQUIRED FOR REPAIR. 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 IT WAS NOT WASHING THE BLOOD, AND TH ROWING ALL THE BLOOD INTO THE DISPOSAL BAG. THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132150 AUTOLOG IQ APPARATUS, AUTOTRANSFUSION CAC PERFUSION SYSTEMS ATLGIQ1 00763000262433

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown