BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 11214542 · Received January 22, 2021

    Report

    Report Number
    8010762-2021-00023
    Event Type
    Malfunction
    Date Received
    January 22, 2021
    Date of Event
    January 14, 2021
    Report Date
    March 30, 2021
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K133598
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A VERY HIGH PART READING DURING PATIENT TREATMENT WAS REPORTED. THE DEVICE WAS MANUFACTURED ON 2016-12-01. THE REVIEW OF THE NON-CONFORMITIES HAS BEEN PERFORMED ON 2021-03-24 FOR THE PERIOD OF 2016-12-01 TO 2021-03-24 . 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 CAN BE EXCLUDED. ON 2021-02-03 A GETINGE SERVICE TECHNICIAN WAS ON SITE. HE COULD NOT CONFIRM THE FAILURE. THE UNIT PASSED ALL TESTS AND GOT BACK IN USE. LOG FILES ANALYSIS OF THE CARDIOHELP SYSTEM WAS PERFORMED ON 2021-03-23 BY GETINGE LIFE-CYCLE ENGINEERING. THE LOG FILES SHOWS THAT THE DEVICE HAD NO MALFUNCTION. WITH REFERENCE TO THE CURRENT RISK ANALYSIS V23 (DMS# 2021972) THE FOLLOWING MOST POSSIBLE CAUSES COULD BE LINKED TO THE REPORTED FAILURE: - DEFIBRILLATOR SYSTEM; - LASER SCALPEL; - CONNECTION OF NON-CAPATIBLE SENOR; - RESPONSE TIME IS TOO LONG ; - POSITIVE OR NEGATIVE PRESSURE BEYOND SPECIFICATION (RELEASE OF TUBES); - TOO HIGH / LOW ATMOSPHERIC PRESSURE. BASED ON THE INVESTIGATION RESULTS ABOVE, THE REPORTED FAILURE "VERY HIGH PART READING " COULD NOT BE CONFIRMED. 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

    COMPLAINT NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    A FOLLOW UP WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A EXCESSIVELY HIGH PART READING WHILE SUPPORTING A PATIENT ON CARDIOHELP WAS REPORTED. THEY SWITCHED TO A DIFFERENT PUMP AND RESOLVED THE ISSUE. COMPLAINTNUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115433 HEART LUNG MACHINE CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH CARDIOHELP

    Patients

    Seq Age Sex Outcome Treatment
    1