BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 18325072 · Received December 14, 2023

    Report

    Report Number
    8010762-2023-00620
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    December 7, 2023
    Report Date
    January 31, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP WILL SUBMITTED WHEN ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT # (B)(4) WAS INITIALLY REPORTED AS LED FOIL OF THE E-DRIVE WAS AFFECTED. HOWEVER, AFTER INVESTIGATION IT WAS CORRECTED AND CONFIRMED THAT THE SPEED INDICATOR ON TOP OF THE CARDIOHELP WAS DEFECTIVE AND THEREFORE THE LED FOIL OF THE E-DRIVE WAS NOT AFFECTED. THUS, THIS EVENT IS NOW CONSIDERED TO BE A NON-REPORTABLE INCIDENT DUE TO THE INVESTIGATION BELOW: THE FAILURE OCCURRED DURING INSPECTION BY GETINGE TECHNICIAN. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON. THE FST DETERMINED THAT THE SIGNAL WIRES OF THE SPEED DISPLAY WERE DISCONNECTED. THE WIRES WERE REPAIRED AND NO PARTS WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. AS FOUND BY THE FST DURING SERVICE, THE ROOT CAUSE WERE SIGNAL INTERFERENCE DUE TO LOOSE SIGNAL OF THE WIRES. FURTHER, ACCORDING TO THE RISK FILE V24 OF THE CARDIOHELP (DMS# 2021972) FOLLOWING IS MENTIONED AS A ROOT CAUSE - DEFECTIVE LED SPEED INDICATOR ADDITIONALLY, ACCORDING TO GETINGE TECHNICAL EXPERTS, THE LED FOIL CANNOT BE INVESTIGATED. THE LED FOIL IS GLUED TO THE HOUSING OF THE CARDIOHELP AND IS THEREFORE DESTROYED DURING DISASSEMBLY. ACCORDING TO THE INSTRUCTION FOR USE (IFU) OF THE CARDIOHELP, CHAPTER 3.3.1 ¿LED SPEED INDICATOR¿ THE SPEED INDICATOR LED ON THE TOP OF THE CARDIOHELP DISPLAYS THE SPEED INDEPENDENTLY OF THE TOUCHSCREEN. IN CASE OF A FAILURE OF THIS COMPONENT, THE SPEED CAN BE STILL OBSERVED BY THE USER ON THE TOUCHSCREEN ACCORDING TO IFU ¿CHAPTER 3.7.5 PARAMETER DISPLAY¿. IT IS STATED IN THE INSTRUCTION FOR USE (CARDIOHELP SYSTEM, CHAPTER 5.6.1 CHECK BEFORE EVERY APPLICATION) THAT THE SPEED INDICATOR LED AND THE TOUCHSCREEN HAVE TO BE CHECKED BEFORE USE. THUS, NO REPORT IS REQUIRED FOR THIS FAILURE. BASED ON THE RESULTS THE REPORTED FAILURE "SPEED INDICATOR ON TOP OF THE CARDIOHELP DOES NOT WORK" COULD BE CONFIRMED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RPM SPEED DISPLAY IS NOT WORKING ON THE HLS DRIVE. THE FAILURE OCCURRED DURING INSPECTION BY GETINGER TECHNICIAN. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780738 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown