BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VARIO TWIN, HL 20 5-PUMPS

    MDR report key: 9484536 · Received December 17, 2019

    Report

    Report Number
    8010762-2019-00396
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    December 4, 2019
    Report Date
    December 17, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL FAILURE DESCRIPTION WAS "BELT SLIP ERROR MESSAGE". A GETINE FIELD SERVICE TECHNICIAN WAS ON SITE TO INVESTIGATE THE PRODUCT IN QUESTION ON 2019-12-06. ACCORDING TO THE SERVICE ORDER 43197062 FOLLOWING WORK HAS BEEN DONE: THE CUSTOMER REPORTED A BELT SLIP ERROR WHILE PRIMING THE CIRCUIT. WHEN I ARRIVE, I DID CONFIRM THE ERROR WHEN THE INCLUSION WAS EXTENDED OUT AGAIN THE TUBING TIGHTLY. WHILE INSPECTING THE BELTS I FOUND THE TIGHTNESS OF THE BELTS WERE IN SPECS READING 384 HZ. I TIGHTENED THE BELTS TO 413 HZ AND TESTED THE UNIT. THE EQUIPMENT WORKS TO SPECS, CLEARED FOR CLINICAL USE. ACCORDING TO THE STATEMENT FROM LIFE CYCLE ENGINEERING ON 2019-11-11 THE MOST PROBABLE ROOT CAUSE IS AS FOLLOWS: A DAMAGED FOIL IS A PLAUSIBLE CAUSE FOR THE MESSAGE "BELT SLIP". BECAUSE THE SENSOR NO LONGER DETECTS ONE OR MORE LINES ON THE FILM, IT MEASURES AN APPARENTLY LOW SPEED AT THE PUMP HEAD. SINCE THIS SPEED IS THEN LOWER THAN THE MOTOR SPEED, THE PUMP INTERPRETS THIS AS A SLIPPING BELT AND DISPLAYS THIS MESSAGE. THE REPORTED FAILURE "BELT SLIP ERROR MESSAGE" OCCURRED DURING PRIMING AND COULD BE CONFIRMED. THE DEVICE WAS DIRECTLY INVOLVED IN THE INCIDENT. THE OCCURENCE RATE IS BELOW THE ACCEPTANCE RATE, THUS NO REMEDIAL ACTION 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 · 1

    "BELT SLIP ERROR" MESSAGE ON HL20 WAS REPORTED WHILE PRIMING THE CIRCUIT. COMPLAINT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1278767 VARIO TWIN, HL 20 5-PUMPS CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS DTQ MAQUET CARDIOPULMONARY GMBH SINGEL PUMP EN ANTI-CLOCKWISE C

    Patients

    Seq Age Sex Outcome Treatment
    1