BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLOG IQ

    MDR report key: 22142589 · Received June 4, 2025

    Report

    Report Number
    2184009-2025-00724
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    May 30, 2025
    Report Date
    August 11, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    CAC
    UDI-DI
    00643169982864
    PMA / PMN Number
    K181954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE REPORTED BLOOD IN WASTE BAG ISSUE WAS VERIFIED DURING SERVICE. SERVICE TECHNICIAN OBSERVED UNIT TO BE CLEAN AND FREE OF DEBRIS, OPERATED UNIT ON HLT MODE, AND OBSERVED LEVEL SENSOR VOLTAGE TO BE SLIGHTLY OUT OF SPEC 99.1 AND 39.4, AND THIS LIKELY IS CAUSE OF THE REPORTED ISSUE. THE ISSUE WAS RESOLVED BY CLEANING THE OPTICS CELL, CALIBRATED LEVEL SENSOR, AND MONITORED THE VOLTAGE TO ENSURE NO DRIFTING, AND VOLTAGES MAINTAINED VALUES. PREVENTIVE MAINTENANCE WAS PERFORMED AS PER SPECIFICATION.  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 NO DAMAGE WAS NOTED IN THE INSTRUMENT OR THE DISPOSABLE. NO VISUAL, AUDIBLE, OR PERFORMANCE ABNORMALITIES WAS OBSERVED. THERE WAS NO LEAK (PRESSURE RELIEF) REPORTED, AND NO TRANSFUSION WAS REQUIRED. THE BOWL OR TUBING WERE NOT RE-SEATED/REINSTALLED/REPLACED. THERE WAS NO ERROR MESSAGE REPORTED. CORRECTION D4: UNIQUE IDENTIFIER (UDI) # FORMAT 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT THE CUSTOMER FOUND RED CELLS SPILLI NG INTO WASTE BAG WHEN THEY THOUGHT IT SHOULD HAVE SWITCHED TO WASH MODE, BUT THE OPERATOR MANUALLY TRIGGERED TO WASH MODE. THE INSTRUMENT WAS USED 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
    709625 AUTOLOG IQ APPARATUS, AUTOTRANSFUSION CAC PERFUSION SYSTEMS ATLGIQ 00643169982864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown