BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 11326759 · Received February 15, 2021

    Report

    Report Number
    8010762-2021-00114
    Event Type
    Malfunction
    Date Received
    February 15, 2021
    Date of Event
    February 8, 2021
    Report Date
    March 25, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE CARDIOHELP SHOWED THE ALARM ¿PUMP DISPOSABLE ERROR¿ AND THE BLOOD FLOW STOPPED. IN ADDITION, THE CONNECTION CABLE FOR INTERNAL SENSORS AND THE VENOUS PROBE CABLE WERE CRACKED. THE DEVICE CAUSED THE COMPLAINT AND WAS NOT ABLE TO WORK AS PER FACTORY SPECIFICATIONS. THE HLS SET WAS SCRAPPED BY THE CUSTOMER. A GETINGE FIELD SERVICE TECHNICIAN WAS ON SITE ON 2021-02-10 TO INVESTIGATE THE DEVICE. HE COULD NOT CONFIRM THE REPORTED FAILURE ¿PUMP DISPOSABLE ERROR¿. THE LOG FILES OF THE CARDIOHELP WERE ANALYZED BY GETINGE TECHNICAL SUPPORT ON 2021-03-23 AND THE REPORTED FAILURE ¿PUMP DISPOSABLE ERROR¿ COULD BE CONFIRMED WITHIN THE LOGS. BASED ON THIS, THE REPORTED FAILURE COULD BE CONFIRMED. ACCORDING TO IFU OF THE HLS SET, CHAPTER 5.3.1 "SAFETY INSTRUCTIONS FOR THE OXYGENATOR" THE MOST PROBABLE ROOT CAUSE OF THE PUMP DISPOSABLE ERROR COULD BE CAUSED BY THE DISPOSABLE WHEN DISCONNECTING FROM THE CARDIOHELP DURING THE PUMP IS RUNNING. THE ERROR CAN ALSO BE CAUSED WHEN THE PUMP IS NOT SET TO ZERO BEFORE CONNECTING THE DISPOSABLE. THE HLS-SET IS NOT AVAILABLE FOR INVESTIGATION, HOWEVER WITH THE PROVIDED LOT NUMBER OF THE SET THE PRODUCTION RECORDS OF THE AFFECTED HLS SET (DMS# 3080183, 3067811, 3073378) AND ALL RELATED COMPONENTS WERE REVIEWED ON 2021-03-25. FOLLOWING TESTS ARE PERFORMED AS A 100 % INSPECTION: FUNCTION TEST. FINAL PRODUCT TEST. ACCORDING TO THE FINAL TEST RESULTS, ALL OXYGENATORS PASSED THE TESTS AS PER SPECIFICATIONS. PRODUCTION RELATED INFLUENCES CAN BE EXCLUDED. DURING INVESTIGATION BY THE FIELD SERVICE TECHNICIAN WAS ON SITE ON 2021-02-10 IT WAS DETECTED THAT THE CONNECTION CABLE FOR DISPOSABLES AND THE VENOUS PROBE CABLE WERE CRACKED. HE REPLACED THE CABLES AND PUT THE DEVICE BACK IN USE AFTER SUCCESSFUL TEST ACCORDING TO FACTORIES SPECIFICATIONS. THE ROOT CAUSE COULD BE LINKED TO THE SHORT VENOUS PROBE CABLE, WHICH WAS REPLACED BY A LONG CABLE. 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS PENDING. THE SALES AND SERVICE UNIT INFORMED THAT THE OXYGENATOR WAS SCRAPPED BY THE CUSTOMER.

    Description of Event or Problem · 1

    COMPLAINT NUMBER: (B)(4). DURING PATIENT TREATMENT IT WAS REPORTED THAT THE CARDIOHELP SHOWED THE ALARM ¿PUMP DISPOSABLE ERROR¿ AND THE BLOOD FLOW STOPPED. AS A MEDICAL INTERVENTION THE EMERGENCY DRIVE WAS USED TO THE BLOOD FLOW. THE DEVICE WAS REPLACED. NO HARM OR NEGATIVE CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225685 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R