BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEART-LUNG BYPASS SYSTEM

    MDR report key: 7472821 · Received April 30, 2018

    Report

    Report Number
    8010762-2018-00158
    Event Type
    Death
    Date Received
    April 30, 2018
    Date of Event
    April 2, 2018
    Report Date
    May 7, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K102726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4).

    Additional Manufacturer Narrative · 0

    MAQUET MEDICAL SYSTEMS, USA(IMPORTER)SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. IMPORTER- MAQUET MEDICAL SYSTEMS USA, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON- (B)(6). THE DEVICE HAS BEEN SENT TO MAHWAH REPAIR DEPOT. REPAIR PERFORMED ON 2018-05-29 AND 2018-05-31. RESULTS OF SUMMARY REPORT 42544326: UNIT WAS UPDATED WITH THE LATEST SW 03.04.08; CARDIO HELP SN# 90410747 HAS BEEN RUNNING WITH A TEST CIRCUIT FOR OVER A MONTH. UNIT HAS BEEN RUNNING 24 HOURS A DAY AT 4,000 RPM¿S HOLDING 3.0 LPM. THE UNIT HAS NOT MADE ONE NOISE. I WAS NOT ABLE TO VERIFY THE CUSTOMER'S COMPLAINT. THE SENSOR PANEL WAS SENT TO LIFE CYCLE ENGINEERING (LCE) IN RASTATT, GERMANY. INVESTIGATION PERFORMED ON 2019-03-11. INVESTIGATION REPORT RECEIVED ON 2019-04-15. RESULTS OF INVESTIGATION REPORT LCE 03935: ALL TESTS PERFORMED IN THE SENSOR PANEL (RUNNING TEST WITH HLS MODULE, TEMPERATURE INCREMENT IN THE PUMP DRIVE) DID NOT SHOW ANY ABNORMALITY AND DID NOT LEAD TO REPRODUCE THE DESCRIBED ERROR AND THEREFORE TO DETERMINE ITS ORIGIN. DUE TO THE FACT THAT THERE ARE NO MOVING OR LOOSE PARTS INSIDE THE PUMP DRIVE OF THE SENSOR PANEL, THE REPORTED NOISE COULD HAVE BEEN GENERATED ONLY BY THE DISPOSABLE. A TEST RUNNING THE HLS MODULE WITHOUT LIQUID INSIDE GENERATED A SCRATCHING NOISE COMING FROM THE DISPOSABLE. THE ASSOCIATED HLS SET WAS NOT PROVIDED FOR THIS INVESTIGATION AND THEREFORE NOT FURTHER INSPECTION CAN BE CAN BE DONE IN THIS DIRECTION. NO ROOT CAUSE COULD BE FOUND. THUS THE FAILURE COULD BE CONFIRMED. SINCE THE SENSOR PANEL HAD NO MALFUNCTION, NO CORRECTIVE ACTION IS NEEDED. IN ADDITION AT THIS TIME IT CANNOT BE CONCLUDED THAT IT IS A SYSTEMIC ERROR. NO CORRECTIVE ACTION IS NEEDED. NOTE: COMPLAINT FOR DISPOSABLE: (B)(4).

    Description of Event or Problem · 0

    CUSTOMER REPORTED ABOUT NOISE COMING FROM THE CARDIOHELP. CIRCUIT WAS ON A PATIENT FOR FOUR DAYS, IT STARTED MAKING AN ODD HUMMING SOUND FROM THE HLS. PATIENT EXPIRED WHILE HE WAS STILL ON THE CIRCUIT. AN ADDITIONAL COMPLAINT FOR THE HLS SET 165185 WAS OPENED IN ORDER TO TRACK AND TREND THE DETECTED FAILURE. (B)(4).

    Description of Event or Problem · 0

    REF.: # (B)(4). CUSTOMER REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314524 HEART-LUNG BYPASS SYSTEM CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY AG CARDIOHELP-I

    Patients

    Seq Age Sex Outcome Treatment
    1 Death