BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 11998086 · Received June 15, 2021

    Report

    Report Number
    8010762-2021-00348
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    June 10, 2021
    Report Date
    July 7, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT DURING TREATMENT THE CUSTOMER WAS HAVING TROUBLE WITH THE FLOW DROPPING. THE CUSTOMER USED THE EMERGENCY DRIVE AND CHANGED THE DEVICE. NO NEGATIVE OUTCOME FOR ANY PERSON WAS REPORTED. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION ON (B)(6) 2021. THE FST COULD NOT CONFIRM THE REPORTED FAILURE AND PUT THE DEVICE BACK IN USE. THE LOGFILE ANALYSIS WAS PERFORMED BY LIFE-CYCLE-ENGINEERING ON (B)(6) 2021. NO MALFUNCTION OF THE DEVICE COULD BE DETECTED. THE DEVICE HISTORY RECORD (DHR) OF THE CARDIOHELP (MATERIAL: 701072780, SERIAL: (B)(6), ELO#: 1071914/V1) FOR WHICH A CUSTOMER COMPLAINT WAS RECEIVED, WAS REVIEWED ON (B)(6) 2021. THE DHR DOES NOT SHOW ANY ABNORMALITY OR ISSUE THAT IS RELATED OR CAN HAVE LED TO THE CUSTOMER COMPLAINT. BASED ON THE INVESTIGATION RESULTS THE REPORTED FAILURE "TROUBLE WITH FLOW DROPPING" COULD NOT BE CONFIRMED. AN EXACT ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, AFTER CONSULTING WITH LIFE-CYCLE-ENGINEERING MOST POSSIBLE CAUSES COULD BE RELATED TO A MALFUNCTION OR MISS-CONNECTION OF THE HLS MODULE, TUBING OR CLAMPS. THE OCCURRENCE RATE WAS CALCULATED FOR THE REPORTED ISSUE AND IT WAS DETERMINED THAT THIS IS NOT A SYSTEMIC ISSUE. THEREFORE, NO REMEDIAL ACTION IS REQUIRED. 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

    COMPLAINTNUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION ARE REQUESTED, BUT STILL PENDING. A FOLLOW-UP EMDR WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HAVING TROUBLE WITH FLOW DROPPING DURING TREATMENT. THE CUSTOMER SWITCHED TO HAND CRANK AND CHANGED THE DEVICES. COMPLAINT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899366 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1