BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOHELP

    MDR report key: 16156647 · Received January 13, 2023

    Report

    Report Number
    8010762-2023-00019
    Event Type
    Malfunction
    Date Received
    January 13, 2023
    Report Date
    February 23, 2023
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED PRESSURE READING ANOMALIES REGARDING PINT AND PART. THE FAILURE OCCURRED DURING TREATMENT. A GETINGE FIELD SERVICE TECHNICIAN (FST) WAS SENT FOR INVESTIGATION AND REPAIR ON 2023-01-28 AND 2023-02-08/09. THE FAILURE COULD NOT BE REPRODUCED. THE DEVICE WAS TESTED FOR A WEEK WITHOUT ANY ISSUES. ALL READINGS WERE WITHIN THE LIMITS AS PER THE PREVENTIVE MAINTENANCE PROTOCOL. NO PARTS WERE REPLACED. THE FST PERFORMED SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. ALL FUNCTION TESTS ARE PASSED. THE LOG FILES ANALYSIS DOES NOT SHOW A MALFUNCTION OF THE CARDIOHELP. THE HLS SET WAS NOT AVAILABLE FOR INVESTIGATION. THUS, NO EXACT ROOT CAUSE COULD BE IDENTIFIED. HOWEVER, ACCORDING TO THE RISK FILE V24 OF THE CARDIOHELP DEVICE (DMS# 2021972) THE FOLLOWING ROOT CAUSES CAN LEAD TO THE REPORTED FAILURE: WRONG PLUGGED EXTERNAL PRESSURE SENSOR OR DISCONNECTION (MIX UP). DISTURBED (EMI) PRESSURE SENSOR. CONNECTION OF NON-COMPATIBLE SENSOR. RESPONSE TIME IS TOO LONG . POSITIVE OR NEGATIVE PRESSURE BEYOND SPECIFICATION (RELEASE OF TUBES). TOO HIGH / LOW ATMOSPHERIC PRESSURE. ACCORDING TO THE INSTRUCTION FOR USE OF THE INVOLVED DISPOSABLES (HLS SET ADVANCED 5.0 / 7.0, HIT SET ADVANCED 5.0 / 7.0, V2.3, CHAPTER 7.1 PREPARATION AND INSTALLATION AND QUADROX-IR SMALL ADULT / ADULT, CHAPTER 7.2 PRIMING THE SYSTEM) THE PRESSURE SENSORS HAVE TO BE CALIBRATED AND CHECKED BEFORE PRIMING. FURTHER THE CARDIOHELP HAS A FLOW/BUBBLE SENSOR AND A VENOUS PROBE TO MEASURE AND CONTROL THE BLOOD FLOW AND PARAMETERS. IF THE MEASURED VALUES ARE ABOVE HIGH LIMIT OR BELOW LOW LIMIT OF THE SET LIMITS THE SYSTEM GENERATES A VISUAL AND ACOUSTICAL ALARM. THE DEVICE WAS MANUFACTURED ON 2017-09-01. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2023-02-21 FOR THE PERIOD OF 2017-09-01 TO 2023-01-09. IT DOES NOT SHOW ANY NON-CONFORMITY IN REGARD TO THE REPORTED PRODUCT AND FAILURE. THERE IS NO INDICATION THAT MANUFACTURING ISSUES OCCURRED DURING THIS TIME, THUS PRODUCTION RELATED INFLUENCES ARE UNLIKELY. BASED ON THE RESULTS THE REPORTED FAILURE "PRESSURE READING ANOMALIES REGARDING PINT AND PART" COULD NOT 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.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP WILL SUBMITTED WHEN ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    COMPLAINT ID: (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED PRESSURE READING ANOMALY'S PINT AND PART. NO HARM TO ANY PERSON HAS BEEN REPORTED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018934 CARDIOHELP CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown