BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 14278069 · Received May 4, 2022

    Report

    Report Number
    8010762-2022-00144
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Report Date
    May 18, 2022
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE LOCKING FLAP FOR PUMP SEGMENT (CLOSING ASSY) IS BROKEN. THE FAILURE OCCURRED DURING PATIENT TREATMENT. THE DEVICE HAS NOT BEEN EXCHANGED DURING TREATMENT. THE TECHNICIAN OF THE HOSPITAL USED TAPE TO FIXATE THE CLOSING ASSY TO THE ROTAFLOW. NO HARM TO ANY PERSON OCCURRED. A GETINGE SERVICE TECHNICIAN WAS ON SITE ON 2022-04-26 TO CHECK THE AFFECTED ROTAFLOW DRIVE (RFD) (SERIAL#(B)(6)). THE TECHNICIAN CONFIRMED THE REPORTED FAILURE AND GAVE THE RFD CLOSING ASSY (MATERIAL#701011680) TO THE TECHNICIAN OF THE HOSPITAL, SINCE THE DEVICE HAS STILL BEEN IN USE ON THE PATIENT. THE TECHNICIAN FROM THE HOSPITAL WILL REPLACE THE RFD CLOSING ASSY (MATERIAL#701011680). AN INVESTIGATION OF A ROTAFLOW SYSTEM THAT EXHIBITED A SIMILAR ISSUE "CLOSING ASSY BROKEN" WAS PERFORMED IN GETINGE LIFE CYCLE ENGINEERING ON 2016-11-02. MOST PROBABLE ROOT CAUSES COULD BE DETERMINED: - TOO EXCESSIVE FORCE; - WEAKENING DUE TO MANUFACTURING ERRORS (AIR INCLUSIONS). THE PRODUCT IN QUESTION WAS PRODUCED IN 2020-07-01. THE DEVICE HISTORY RECORD (DHR) OF THE ROTAFLOW (MATERIAL:701022161 , SERIAL: (B)(6), ELO#:1072939) FOR WHICH A CUSTOMER COMPLAINT WAS RECEIVED, WAS REVIEWED ON 2022-04-22. THE DHR DOES NOT SHOW ANY ABNORMALITY OR ISSUE THAT IS RELATED OR CAN HAVE LED TO THE CUSTOMER COMPLAINT. 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. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LOCKING FLAP FOR PUMP SEGMENT (CLOSING ASSY) IS BROKEN. THE FAILURE OCCURRED DURING PATIENT TREATMENT. THE DEVICE HAS NOT BEEN EXCHANGED DURING TREATMENT. THE CUSTOMER USED A BAND TO FIXATE THE BROKEN PART. NO HARM 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
    1822805 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW GERMAN EU-PLUG ICU

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention