BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 20817167 · Received December 2, 2024

    Report

    Report Number
    8010762-2024-0000578
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 29, 2024
    Report Date
    February 7, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 2024-12-13. THE FAILURE COULD BE REPRODUCED AND THE OPTICAL TACHO BOARD IS SUSPECTED TO BE DEFECT. DUE TO THE AGE OF THE DEVICE (OVER 20 YEARS OLD) THE CUSTOMER DECIDED NOT TO REPAIR THE DEVICE. THE AFFECTED PARTS WERE NOT MADE AVAILABLE FOR FURTHER INVESTIGATION AT THE MANUFACTURER. THE REPORTED ERROR MESSAGE "HEAD" COULD BE LINKED TO THE FOLLOWING MOST PROBABLE ROOT CAUSES ACCORDING TO THE RISK ASSESSMENT FILE: FAIL OF DEVICE BECAUSE OF: (TOTAL) FAIL OF DEVICE BECAUSE OF: - FAILURE OF MOTOR, MOTOR CONTROLLER OR CONTROL CIRCUITRY - FAILURE OF PUMP CONTROL BOARD (PUMP STOP) - PUMP ON/OFF DEFECTIVE - DEFECTIVE TACHO, RELAY OR PUMP BELT DUE TO THE AGE OF THE DEVICE AND THE MOTOR CONTROL BOARDS (OVER 20 YEARS OLD), AGE RELATED ASPECTS CAN BE CONSIDERED AS WELL. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2024-11-29 FOR THE PERIOD OF 2004-10-08 TO 2024-11-29. 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 2004-10-08. 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 2004. ALL MAQUET CARDIOPULMONARY CLASS II PRODUCTS MANUFACTURED UNTIL 2015 DO NOT HAVE UDI ENTRIES. THEREFORE, NO UDI NUMBER IS AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. A GETINGE TECHNICIAN WILL INVESTIGATE THE HL 20. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THIS MACHINE (HL 20) HAS BEEN MANUFACTURED ON 2004. 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

    COMPLAINT ID#(B)(4).

    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. 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).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105615 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH HL 20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown