BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART LUNG MACHINE

    MDR report key: 10418852 · Received August 18, 2020

    Report

    Report Number
    8010762-2020-00263
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    August 11, 2020
    Report Date
    October 30, 2020
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KFM
    PMA / PMN Number
    K991864
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED FAILURE "HEAD ERROR" WAS DISCOVERED BEFORE TREATMENT. THE AFFECTED ROTAFLOW DRIVE (RFD) HAS BEEN REQUESTED FOR REPAIR AT THE MANUFACTURER UNDER RMA#41851. 2020-08-28: DRIVE RECEIVED. 2020-09-30: FUNCTION TEST AT THE SERVICE DEPARTMENT IN RASTATT. 2020-10-29: SERVICE REPORT RMA 2020-10336 RECEIVED. ACCORDING TO THE SERVICE ORDER RMA 2020-10336 DATED ON 2020-10-19 HAS THE AFFECTED DRIVE BEEN INVESTIGATED. THE MC 1 AND MC 2 HAVE TRIGGERED THE ERROR MESSAGE "HEAD ERROR". THE MC 1 AND MC 2 HAVE BEEN REPLACED. THE CLOSING ASSY AND THE FLOW SENSOR HAVE BEEN REPLACED. MOST POSSIBLE ROOT CAUSE COULD BE DETERMINED AS MISHANDLING. ACCORDING TO THE SERVICE REPORT 10478534 DATED ON 2020-10-29 WAS THE ROTAFLOW DRIVE FUNCTION TESTED AT THE SERVICE DEPARTMENT IN RASTATT. A SYSTEM TEST WAS PERFORMED ACCORDING TO THE SERVICE PROTOCOL. ALL TESTS WERE PASSED. FURTHERMORE, THE INSTRUCTIONS FOR USE OF THE ROTAFLOW SYSTEM, SEE ROTAFLOW SYSTEM USER MANUEL, INSTRUCTIONS FOR USE / 4.2 / EN / 13, CHAPTER 8.1.2 CONTAIN DETAILED DESCRIPTIONS TO PREVENT AN ¿ERROR HEAD¿. THE REPORTED FAILURE "HEAD ERROR" OCCURRED BEFORE TREATMENT. THE DEVICE WAS DIRECTLY INVOLVED IN THE EVENT AND NOT ABLE TO MEET ITS SPECIFICATIONS. THE FAILURE COULD 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 ID:354580.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A ROTAFLOW DRIVE DISPLAYS "HEAD ERROR" AFTER STARTUP TEST. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    886355 HEART LUNG MACHINE PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOPULMONARY GMBH ROTAFLOW

    Patients

    Seq Age Sex Outcome Treatment
    1