BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLOG IQ

    MDR report key: 21122077 · Received January 10, 2025

    Report

    Report Number
    2184009-2025-00018
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    January 3, 2025
    Report Date
    January 10, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    CAC
    UDI-DI
    00643169982864
    PMA / PMN Number
    K181954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE REPORTED ISSUE OF THE DEVICE SENDING GOOD BLOOD TO THE WASTE BAG WAS VERIFIED DURING SERVICE. DURING INSPECTION SERVICE TECHNICIAN FOUND THE EMITTER AND DETECTOR GAIN AND OFFSET WERE OUT OF CALIBRATION. UPON FURTHER INSPECTION SERVICE TECHNICIAN FOUND THAT THERE WAS BLOOD AND FLUID EGRESS INSIDE THE CENTRIFUGE, DAMPER AND THE OPTICS SENSORS THEMSELVES. SERVICE TECHNICIAN THOROUGHLY CLEANED THE CENTRIFUGE AND DAMPER. THE ISSUE WAS RESOLVED BY REPLACING THE CABLE ASSEMBLY, ASSY OPTICS LEVEL SENSOR DETECTOR AND ASSY OPTICS LEVEL SENSOR EMITTER. SERVICE TECHNICIAN VERIFIED AND CALIBRATED THE OPTICS SENSORS WERE READING PROPERLY AND COMPLETED A FULL DIAGNOSTIC CHECK AND HLT. POST REPAIR TESTING WAS PERFORMED PER SPECIFICATIONS. NOTE: THE INSTRUMENT WAS ANALYSED BY A FIELD SERVICE TECHNICIAN WITHIN THE FACILITY. THE INSTRUMENT DID NOT RETURN TO A MEDTRONIC FACILITY FOR ANALYSIS. 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 SENDING GOOD BLOOD TO THE WASTE BAG. 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
    1418379 AUTOLOG IQ APPARATUS, AUTOTRANSFUSION CAC PERFUSION SYSTEMS ATLGIQ 00643169982864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown