BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOLOG IQ

    MDR report key: 20555702 · Received October 29, 2024

    Report

    Report Number
    2184009-2024-00663
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    October 16, 2024
    Report Date
    January 8, 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 SUMMARY: THE REPORTED BLOOD SENT TO WASTE BAG ISSUE WAS VERIFIED DURING SERVICE. SERVICE TECHNICIAN OBSERVED THE OPTICS WERE OUT OF SPECIFICATION. THE ISSUE WAS RESOLVED BY REPLACING THE OPTICS EMITTER, CABLE ASSY LEVEL SENSOR, AND DETECTOR. CONFIRMED CALIBRATION AND COMPLETED THE HLT. 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

    B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO VISIBLE DAMAGE TO THE AUTOLOG OR THE WASH KIT. THE ONLY ABNORMALITY WAS THAT THE WASTE BAG WAS FULL OF WHOLE BLOOD, THE WASH VOLUME READ 0 ML, AND PROCESSED VOLUME READ 0 ML. THE BLOOD WAS SPUN IN THE CENTRIFUGE AND ALL OF IT WENT TO THE WASTE BAG. THE CUSTOMER DID NOT BOTHER REPLACING THE WASH KIT SINCE THEY ALREADY KNEW THE SAME EXACT PROBLEM HAPPENED ON THE SAME INSTRUMENT WITH A DIFFERENT WAS KIT IN A PREVIOUS CASE. THE CUSTOMER DOES NOT RECALL THE LEVEL OF THE RESERVOIR WHEN THE ISSUE OCCURRED. THE SALINE BAGS EACH STILL HAD 1000ML IN THEM, THE HOLDING BAG WAS EMPTY, AND ALL THE VOLUME HAD BEEN SENT TO THE WASTE BAG, THE CUSTOMER WAS UNSURE OF THE EXACT AMOUNT IN THE WASTE BAG. NO ERROR OR WARNING MESSAGE APPEARED ON THE SCREEN. APPROXIMATELY 250 ML OF BLOOD WAS LOST. A TRANSFUSION WAS NOT REQUIRED. CORRECTION B.3 EVENT DATE AND CORRECTION TO NOTIFY DATE 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 DURING USE OF AN AUTOLOG IQ INSTRUMENT, IT WAS REPORTED THAT THE UNIT IS 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
    923638 AUTOLOG IQ APPARATUS, AUTOTRANSFUSION CAC PERFUSION SYSTEMS ATLGIQ 00643169982864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown