BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET

    MDR report key: 17180336 · Received June 22, 2023

    Report

    Report Number
    8010762-2023-00303
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Report Date
    June 28, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE INTERNAL PRESSURES ARE UNSTABLE (READING TO HIGH). THE HLS CABLE WAS RUSTY AND EXCHANGED, BUT THIS DID NOT SOLVED THE ISSUE. THE HLS SET IS STILL USED FURTHER ON THE PATIENT. THE FAILURE OCCURRED DURING TREATMENT. ON 2023-06-27 THE INFORMATION WAS RECEIVED, THAT THE CARDIOHELP WAS INVESTIGATED AND THE SENSOR PANEL CAUSED THE PRESSURE READING ISSUE. THE CARDIOHELP WILL BE INVESTIGATED IN COMPLAINT# (B)(4) (MFG REPORT NUMBER 8010762-2023-00302). THEREFORE THE ROOT CAUSE FOR THE REPORTED FAILURE "PRESSURE READING UNSTABLE" IS NARROWED DOWN TO THE CARDIOHELP DEVICE. BASED ON THE RESULTS THE REPORTED FAILURE "PRESSURE READING UNSTABLE" COULD BE CONFIRMED, BUT WAS NOT RELATED TO THE HLS SET. THIS COMPLAINT WAS FOUND IN THE DATABASE OF CUSTOMER COMPLAINTS FOR THE HLS DEVICE AS A SINGLE EVENT (TIMEFRAME FROM 2022-06-20 TILL 2023-06-20). THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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.

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINT ID# 842742

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTERNAL PRESSURES ARE UNSTABLE (READING TO HIGH). THE FAILURE OCCURRED DURING TREATMENT. THE HLS CABLE WAS RUSTY AND EXCHANGED, BUT THIS DID NOT SOLVED THE ISSUE. THE HLS SET IS STILL IN USE ON THE PATIENT.THE CARDIOHELP WILL BE INVESTIGATED IN COMPLAINT# (B)(4). NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028592 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown