BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 17359655 · Received July 20, 2023

    Report

    Report Number
    8010762-2023-00345
    Event Type
    Malfunction
    Date Received
    July 20, 2023
    Date of Event
    June 30, 2023
    Report Date
    October 27, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW UP WILL SUBMITTED WHEN ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE HAND CRANK WON¿T TURN WITH AN ATTACHED HLS CABLE. THE EVENT OCCURRED ON A GETINGE LOANER UNIT IN THE NATIONAL REPAIR CENTER DURING PREVENTIVE MAINTENANCE. AS CONFIRMED BY GETINGE DEPOT CENTER THE FAILURE WAS FOUND DURING FINAL TEST AND THE E-DRIVE WAS PUT OUT OF USE. ANOTHER E-DRIVE WITH THE SAME FAILURE WAS INVESTIGATED BY GETINGE LIFE-CYCLE-ENGENEERING ON 2023-08-17 WITH THE FOLLOWING RESULTS (SEE COMPLAINT#(B)(4)): THE EXAMINATION OF THE E-DRIVE SHOWED THAT THE INSTALLED SCHNORR RETAINING WASHER, THE BULGING OF THE MAGNETIC HOLDING DISC BY 0.4MM AND DUE TO THE ATTACHMENT OF THE RETAINING RING AND AN UNFAVORABLE TOLERANCE IN ADDITION TO THE INDIVIDUAL COMPONENTS CAN LEAD TO THE FAILURE OF THE E-DRIVE. FOR THIS FAILURE THE NC 3040766 WAS INITIATED. OUT OF THIS NC A FSCA WAS INITIATED ON 2023-10-05 TO TAKE ACTIONS. THUS, THIS COMPLAINT IS IN SCOPE OF FSCA 874872 . ALL FURTHER REPORTS/COMMUNICATION WITH THE AUTHORITIES WILL PERFORMED THROUGH FSCA 874872 . ACCORDING TO THE INSTRUCTION FOR USE OF THE CARDIOHELP DEVICE (CHAPTER 5.6.1 "CHECK BEFORE EVERY APPLICATION") THE EMERGENCY DRIVE MUST BE CHECKED BEFORE USE. THE DEVICE WAS MANUFACTURED ON 2022-11-23. THE DEVICE HISTORY RECORD (DHR) OF THE CARDIOHELP (MATERIAL: (B)(4), SERIAL: (B)(6)) WAS REVIEWED ON 2023-07-04. THERE IS NO INDICATION THAT OTHER MANUFACTURING ISSUES OCCURRED. BASED ON THE RESULTS THE REPORTED FAILURE "HAND CRANK WON¿T TURN" COULD BE CONFIRMED. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP WILL SUBMITTED WHEN ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAND CRANK WILL NOT TURN WITH AN ATTACHED HLS CABLE. THE EVENT OCCURRED ON A GETINGE LOANER UNIT IN THE NATIONAL REPAIR CENTER DURING PREVENTIVE MAINTENANCE. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HAND CRANK WON¿T TURN WITH AN ATTACHED HLS SET. THE EVENT OCCURRED ON A GETINGE LOANER UNIT IN THE NATIONAL REPAIR CENTER DURING PREVENTIVE MAINTENANCE. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754679 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown