BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS SET ADVANCED

    MDR report key: 13469878 · Received February 7, 2022

    Report

    Report Number
    8010762-2022-00042
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    February 3, 2022
    Report Date
    February 7, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. FURTHER INFORMATION AND RETURN OF THE PRODUCT HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN THE USA DURING TREATMENT. IT WAS REPORTED THAT THE VENOUS PRESSURE WAS NOT MEASURED. NO HARM TO ANY PERSON REPORTED. THE RETURNED PRODUCT WAS INVESTIGATED AT THE LABORATORY OF THE MANUFACTURER. DURING A FUNCTIONALITY CHECK OF THE SENSORS NO VENOUS PRESSURE WAS MEASURED BY THE CARDIOHELP DEVICE. THE VISUAL INSPECTIONS DID NOT REVEAL ANY GENERAL DAMAGE OR DEVIATIONS IN THE ELECTRONIC COMPONENTS. FINALLY, THE CAUSE OF THE ERROR CAN BE REDUCED TO THE VENOUS PRESSURE SENSOR, SINCE NO DEVIATIONS WERE FOUND ON THE FLEXIBLE CONDUCTOR, THE HLS CONNECTOR, OR THE CONNECTION BETWEEN THE FLEXIBLE CONDUCTOR AND THE PRESSURE SENSOR. THE PRODUCTION RECORDS OF THE AFFECTED HLS MODULE (BATCH 3000194187, 3000197830, 3000197831 ) WERE REVIEWED . FOLLOWING TESTS ARE PERFORMED AS A 100 % INSPECTION: GLUING OF SENSORS . GLUING OF COVER FOR TEMPERATURE AND PRESSURE SENSOR . FUNCTIONALITY TEST HLS MODULE (SENSORS AND PUMP). ACCORDING TO THE FINAL TEST RESULTS, THE OXYGENATOR WITH THE SERIAL# 1820427 PASSED THE TEST AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES ARE UNLIKELY TO HAVE CONTRIBUTED TO THE REPORTED FAILURE. THUS THE REPORTED FAILURE "PVEN SENSOR FAILURE" WAS CONFIRMED DURING INVESTIGATION AND WAS MOST PROBABLE CAUSED BY A ELECTRONIC MALFUNCTION OF THE VENOUS PRESSURE SENSOR. IT WAS NOT POSSIBLE TO DETERMINE THE EXACT ROOT CAUSE. THE REPORTED FAILURE DID NOT CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH. SINCE NO SYSTEMIC ISSUE WAS DETERMINED NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN THE USA DURING TREATMENT. IT WAS REPORTED THAT THE VENOUS PRESSURE WAS NOT MEASURED. NO HARM TO ANY PERSON REPORTED. COMPLAINT: (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595329 HLS SET ADVANCED OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BEQ-HLS 7050 USA 3000197830 OR 3000197831

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown