BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET

    MDR report key: 20415059 · Received October 10, 2024

    Report

    Report Number
    8010762-2024-0000487
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Report Date
    October 10, 2024
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    PMA / PMN Number
    K112360
    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 THERE WAS A NEGATIVE FLOW READING WITH RPM UP IN NORMAL RANGE. THE FAILURE OCCURRED DURING TREATMENT. THE HLS SET WAS EXCHANGED, BUT DID NOT SOLVE THE ISSUE. THEREFORE, THE CARDIOHELP DEVICE WAS SWITCHED OUT AND THE UNIT WAS TAGGED OUT OF SERVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. FURTHER THE INFORMATION WAS RECEIVED THAT THERE WAS NO EXTERNAL DAMAGE ON THE FLOW BUBBLE SENSOR NOR FOREIGN MATERIAL WAS BUILD UP ON THE SENSOR. THE ERROR MESSAGE BACKFLOW PREVENTION WAS DISPLAYED DUE TO THE FLOW ISSUES. THE CARDIOHELP WAS INVESTIGATED IN COMPLAINT# (B)(4) (MFG REPORT NUMBER 8010762-2024-0000486) AND NO ISSUE ON THE CARDIOHELP DEVICE COULD BE FOUND. ON 2024-10-08 NEW INFORMATION WAS RECEIVED THAT THE CUSTOMER DID NOT FIND ANY ISSUE WITH THEIR DISPOSABLE. THE DISPOSABLE IS NOT AVAILABLE FOR INVESTIGATION. AS THE FAILURE HAPPENED DURING TREATMENT AND THE HLS SET WAS EXCHANGED, A REPORT IS REQUIRED. THE LOG FILES OF THE REPORTED CARDIOHELP DEVICE WERE REVIEWED AND THE ERROR MESSAGE "BACKFLOW PREVENTION" COULD BE CONFIRMED ON THE DATE OF EVENT AS THE PRODUCT IS NOT AVAILABLE FOR TECHNICAL INVESTIGATION, NO EXACT ROOT CAUSE REMAINS UNKNOWN. HOWEVER, ACCORDING TO THE RISK ASSESSMENT OF THE HLS SET, THE FOLLOWING ROOT CAUSE CAN LEAD TO THE REPORTED FAILURE: - INTERRUPTED PRELOAD - CAVITATION - TOO LOW COLLECTION OF VENOUS RETURN - PUMP DOWN REGULATION. A DEVICE HISTORY REVIEW COULD NOT BE PERFORMED, AS THE PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION AND NO LOT# OF THE AFFECTED PRODUCT WAS PROVIDED. BASED ON THE RESULTS THE REPORTED FAILURE "NEGATIVE FLOW/NO FLOW" COULD BE CONFIRMED. THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. 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. NOTE: NO UDI NUMBER HAS BEEN INCLUDED IN THE SECTION D4 UNIQUE DEVICE IDENTIFIER (UDI) SINCE THE LOT NUMBER OF THE AFFECTED SET WAS NOT PROVIDED. THE DISPOSABLE IS NOT AVAILABLE FOR INVESTIGATION AND NO FURTHER INFORMATION WAS RECEIVED. THEREFORE IT IS NOT POSSIBLE TO IDENTIFY THE SET LOT NUMBER OF THE DEVICE IN QUESTION AND THEREFORE ITS UDI NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A NEGATIVE FLOW READING WITH RPM UP IN NORMAL RANGE. THE FAILURE OCCURRED DURING TREATMENT. THE HLS SET WAS EXCHANGED, BUT DID NOT SOLVE THE ISSUE. THEREFORE, THE CARDIOHELP DEVICE WAS SWITCHED OUT AND THE UNIT WAS TAGGED OUT OF SERVICE. NO HARM TO ANY PERSON HAS BEEN REPORTED. FURTHER THE INFORMATION WAS RECEIVED THAT THERE WAS NO EXTERNAL DAMAGE ON THE FLOW BUBBLE SENSOR NOR FOREIGN MATERIAL WAS BUILD UP ON THE SENSOR. THE ERROR MESSAGE BACKFLOW PREVENTION WAS DISPLAYED DUE TO THE FLOW ISSUES. THE CARDIOHELP WAS INVESTIGATED IN COMPLAINT# (B)(4) (MFG REPORT NUMBER 8010762-2024-0000486) AND NO ISSUE ON THE CARDIOHELP DEVICE COULD BE FOUND. ON 2024-10-08 NEW INFORMATION WAS RECEIVED THAT THE CUSTOMER DID NOT FIND ANY ISSUE WITH THEIR DISPOSABLE. THE DISPOSABLE IS NOT AVAILABLE FOR INVESTIGATION. AS THE FAILURE HAPPENED DURING TREATMENT AND THE HLS SET WAS EXCHANGED, A REPORT IS REQUIRED. COMPLAINT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1816588 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown