BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 21856985 · Received April 17, 2025

    Report

    Report Number
    8010762-2025-0000169
    Event Type
    Malfunction
    Date Received
    April 17, 2025
    Date of Event
    March 28, 2025
    Report Date
    May 14, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE TECHNICIAN WILL BE SENT FOR FURTHER INVESTIGATION OF THE DEVICE. AS SOON AS NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A HL20 PUMP DISPLAYED THE ERROR MESSAGE: "HEAD". THE EVENT OCCURRED PRIOR TO USE. NO HARM TO ANY PERSON WAS REPORTED. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR. NO PARTS WAS REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE GETINGE FIELD SERVICE TECHNICIAN THE STROBE FOIL WAS CLEANED AND ALL CONNECTIONS OF THE TACHO BOARD AND THE MOTOR CONTROL BOARD WERE RESET, WHICH SOLVED THE FAILURE. A SIMILAR CASE WAS ASSESSED BY THE GETINGE LIFE CYCLE ENGINEERING ON 2024-03-04. BECAUSE THE ERROR "ERROR HEAD" WAS RESOLVED BY REFITTING OF ALL CIRCUIT BOARD CONNECTIONS THE MOST PROBABLE ROOT CAUSE WAS DETERMINED AS COMMUNICATION DISTURBANCES DUE TO TRANSITION RESISTANCE THAT CAN ARISE FROM SURFACE CORROSION. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2025-04-14 FOR THE PERIOD OF 2005-09-02 TO 2025-03-28. 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 2005-09-02. 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 INVESTIGATION RESULTS THE REPORTED FAILURE "HEAD" COULD BE CONFIRMED. 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

    THE EVENT OCCURRED IN ITALY PRIOR TO USE. IT WAS REPORTED THAT A HL20 PUMP DISPLAYED THE ERROR MESSAGE: "HEAD". NO HARM TO ANY PERSON HAS BEEN REPORTED. ACCORDING TO THE HL20 SERVICE MANUAL THE ERROR "HEAD" INDICATES THAT THE MOTOR TACHO SHOWS A VALUE BUT THE HEAD TACHO SHOWS 0 (ZERO). THE FAILURE CAN CAUSE AN UNINTENTIONAL PUMP STOP. THEREFORE, A REPORT IS REQUIRED. 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
    1681271 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown