BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLOG IQ

    MDR report key: 21206540 · Received January 22, 2025

    Report

    Report Number
    2184009-2025-00058
    Event Type
    Malfunction
    Date Received
    January 22, 2025
    Date of Event
    March 8, 2024
    Report Date
    January 22, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    CAC
    UDI-DI
    00643169982864
    PMA / PMN Number
    K181954
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE REPORTED BLOOD SENT TO WASTE BAG ISSUE WAS VERIFIED DURING SERVICE. SERVICE TECHNICIAN OBSERVED UNIT TO BE CLEAN AND FREE OF DEBRIS. OPERATED DEVICE THROUGH HLT DIAGNOSTIC MODE. IDENTIFIED LEVEL SENSOR VOLTAGES TO BE AT 38MVDC AND 97MVDC. THE ISSUE WAS RESOLVED BY CLEANING THE OPTICS AND CALIBRATED TO 40MVDS AND 100MVDC. VOLTAGES HELD STRONG, AND NO DRIFTING WAS OBSERVED. PREVENTIVE MAINTENANCE WAS PERFORMED AS PER SPECIFICATION. D9: INSTRUMENT WAS SERVICED AT THE FACILITY BY MEDTRONIC FIELD SERVICE AND WAS NOT RETURNED TO MEDTRONIC SERVICE CENTER THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW THROUGH CAPA 624392 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 WHILE PROCESSING BLOOD, IT SPILLED INTO WASTE BAG AND WAS NOT DETECTED. THE UNIT WAS REMOVED FROM USE. THIS WAS THE FIRST USE OF THE UNIT SINCE BEING UNBOXED. 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
    842375 AUTOLOG IQ APPARATUS, AUTOTRANSFUSION CAC PERFUSION SYSTEMS ATLGIQ 00643169982864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown