BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 18291692 · Received December 8, 2023

    Report

    Report Number
    8010762-2023-00612
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    November 7, 2023
    Report Date
    December 8, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT OCCURRED IN THE USA DURING PRE-USE SETUP OF THE ROTAFLOW (RF). IT WAS REPORTED THAT THE ERROR MESSAGE ¿B TEMP" ERROR WAS DISPLAYED ON THE ROTAFLOW CONSOLE, AND THAT THE ROTAFLOW EMERGENCY-DRIVE (RFE) HANDLE WAS DAMAGED. NO HARM TO ANY PERSON HAS BEEN REPORTED. A GETINGE SERVICE TECHNICIAN INVESTIGATED THE ROTAFLOW CONSOLE (RFC) WITH SERIAL NUMBER (SN) (B)(6). THE TECHNICIAN CONFIRMED THE REPORTED FAILURE AND REPLACED THE "BATTERY PACK WITH FUSE" (MATERIAL# 70101.7188). THE TECHNICIAN ALSO INVESTIGATED THE RFE WITH SN (B)(6) AND REPLACED THE "RFE HAND CRANK ASSY" (MATERIAL# 70103.7579). AFTER THE REPLACEMENTS THE ROTAFLOW IS WORKING AS INTENDED. AN INVESTIGATION OF A ROTAFLOW SYSTEM THAT EXHIBITED A SIMILAR ISSUE "B TEMP ERROR" HAS BEEN PERFORMED BY GETINGE LIFE CYCLE ENGINEERING: THE MOST PROBABLE ROOT CAUSE COULD BE DETERMINED AS A DISPLACED CONTACT DUE TO INCORRECT ASSEMBLY OF THE CONNECTOR ON THE BATTERY PACK, WHICH LED TO THE REPORTED "B TEMP" ERROR. THE MOST PROBABLE ROOT CAUSE FOR THE DAMAGED EMERGENCY DRIVE HANDLE COULD BE IDENTIFIED AS NORMAL WEAR AND TEAR OF THE DEVICE (PRODUCED IN 2015). BASED ON THESE INVESTIGATION RESULTS THE REPORTED FAILURES "B TEMP ERROR" AND "ROTAFLOW EMERGENCY-DRIVE DAMAGED" COULD BE CONFIRMED. A REVIEW OF NON-CONFORMITIES WAS PERFORMED ON 2023-12-07, AND DURING THE TIME FROM 2015-09-15 TO 2023-12-07 THERE ARE NO NON-CONFORMITIES 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 ROTAFLOW CONSOLE IN QUESTION WAS PRODUCED ON 2015-09-15. 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 THE USA DURING PRE-USE SETUP OF THE ROTAFLOW. IT WAS REPORTED THAT THE ERROR MESSAGE ¿B TEMP¿ WAS DISPLAYED ON THE ROTAFLOW CONSOLE, AND THAT THE ROTAFLOW EMERGENCY-DRIVE HANDLE WAS DAMAGED. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213202 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW ENGLISH/US US-PLUG ICU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown