BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 21661569 · Received March 21, 2025

    Report

    Report Number
    8010762-2025-0000126
    Event Type
    Malfunction
    Date Received
    March 21, 2025
    Date of Event
    March 9, 2025
    Report Date
    March 20, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A HL 20 PUMP DISPLAYED THE ERROR MESSAGE "HEAD". THE EVENT OCCURRED DURING A ROUTINE CHECK. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE FAILURE CAN CAUSE AN UNINTENTIONAL PUMP STOP. THEREFORE A REPORT IS REQUIRED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR "HEAD" INDICATES THAT THE MOTOR TACHO SHOWS A VALUE BUT THE HEAD TACHO SHOWS 0 (ZERO). A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2025-03-20. THE FAILURE COULD BE REPRODUCED. ALL CONTROL BOARDS AND THE OPTICAL TACHO BOARD WERE CLEANED. NO PARTS WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. ACCORDING TO THE GETINGE FIELD SERVICE TECHNICIAN THE MOST PROBABLE ROOT CAUSE WAS DETERMINED AS INCORRECT RELATIVE HUMIDITY. AS CONFIRMED BY THE GETINGE FIELD SERVICE TECHNICIAN ON 2025-03-20 THE MOST PROBABLE ROOT CAUSE WAS DETERMINED AS TOO HIGH HUMIDITY WHICH CAUSED CONDENSATION. THE MAIN REASON HOW HUMIDITY LEADS TO A MALFUNCTION IS CONDENSATION, WHICH CAN LEAD TO REDUCED INSULATION RESISTANCE AND EVEN SHORT CIRCUITS. DUE TO THE AGE OF THE DEVICE (OVER 10 YEARS OLD), AGE RELATED ASPECTS CAN BE CONSIDERED AS WELL. THE CUSTOMER WAS INSTRUCTED TO FOLLOW THE INSTRUCTION FOR USE. ACCORDING TO THE INSTRUCTION FOR USE FOR THE HL20 CHAPTER 13.5 AMBIENT CONDITIONS THE RELATIVE HUMIDITY (NON-CONDENSING) SHOULD BE KEPT IN THE RANGE OF 30 ¿ 85% DURING OPERATION AND BETWEEN 10 ¿ 96% DURING STORAGE. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-03-20 FOR THE PERIOD OF 2014-02-06 TO 2025-03-09. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. THE DEVICE WAS MANUFACTURED ON 2014-02-06. IN ADDITION A REVIEW FOR POTENTIAL FIELD ACTIONS AND CAPAS RELATED TO THE FAILURE AND PRODUCT IN THIS COMPLAINT WAS PERFORMED. THIS COMPLAINT IS NOT IN SCOPE OF ANY ONGOING FIELD ACTIONS AND/OR CAPAS. BASED ON THE RESULTS THE REPORTED FAILURE " ERROR MESSAGE HEAD" 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. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THIS MACHINE (HL 20) HAS BEEN MANUFACTURED ON 2014. ALL MAQUET CARDIOPULMONARY CLASS II PRODUCTS MANUFACTURED UNTIL 2015 DO NOT HAVE UDI ENTRIES. THEREFORE, NO UDI NUMBER IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A HL 20 PUMP DISPLAYED THE ERROR MESSAGE "HEAD". THE EVENT OCCURRED DURING A ROUTINE CHECK. NO HARM TO ANY PERSON HAS BEEN REPORTED. THE FAILURE CAN CAUSE AN UNINTENTIONAL PUMP STOP. THEREFORE A REPORT IS REQUIRED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR "HEAD" INDICATES THAT THE MOTOR TACHO SHOWS A VALUE BUT THE HEAD TACHO SHOWS 0 (ZERO). COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369370 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown