BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 17387543 · Received July 25, 2023

    Report

    Report Number
    8010762-2023-00353
    Event Type
    Malfunction
    Date Received
    July 25, 2023
    Date of Event
    July 19, 2023
    Report Date
    October 25, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    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

    IT WAS REPORTED THAT A E-DRIVE WILL BE RETURNED TO THE MANUFACTURER DUE TO A WASHER ISSUE. THE FAILURE OCCURRED IN THE GETINGE NATIONAL REPAIR CENTER. AS CONFIRMED BY THE GETINGE DEPOT CENTER THE FAILURE WAS FOUND DURING FINAL TESTING AND THE E-DRIVE WAS PUT OUT OF USE. ANOTHER E-DRIVE WITH A SIMILAR FAILURE WAS INVESTIGATED BY GETINGE LIFE-CYCLE-ENGINEERING ON 2023-08-17 WITH THE FOLLOWING RESULTS: 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 A FSCA 874872 WAS INITIATED ON 2023-10-05 WITH THE FOLLOWING ACTION: REMOVAL OF THE SAFETY WASHER FOR ALL CARDIOHELP WITH AFFECTED EMERGENCY DRIVES. 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 2022-09-30. THE DEVICE HISTORY RECORD (DHR) OF THE CARDIOHELP (MATERIAL: 701072780, SERIAL: (B)(6) ) WAS REVIEWED ON 2023-08-10. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY TO HAVE CONTRIBUTED TO THE REPORTED FAILURE. BASED ON THE RESULTS THE REPORTED FAILURE "E-DRIVE WILL RETURNED TO MANUFACTURER DUE TO WASHER ISSUE " 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.

    Additional Manufacturer Narrative · 0

    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 WITH THE FOLLOWING RESULTS: 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. FURTHER INVESTIGATION STILL ONGOING. A FOLLOW UP WILL SUBMITTED, WHEN ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A E-DRIVE WILL BE RETURNED TO MANUFACTURER FOR INVESTIGATION, E-DRIVE WAS NON-FUNCTIONAL IN THE NATIONAL REPAIR CENTER. NO HARM TO ANY PERSON 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
    1271657 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown