BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 3904463 · Received May 28, 2014

    Report

    Report Number
    1828100-2014-00462
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 5, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) WAS WORKING WITH TECHNICAL SUPPORT TO GET PART NUMBERS FOR THE REPAIR. BIOMED TOOK THE PUMP APART AND IT LOOKS LIKE THE IMPELLERS WERE WOBBLY. THE BIOMED REPLACED THE PUMP AT THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SET-UP OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE COOLER HEATER UNIT WAS NOISY. THE UNIT WAS INTERMITTENTLY FUNCTIONING. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO DELAYS, NO BLOOD LOSS, OR NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315004 DUAL COOLER/HEATER SARNS DUAL COOLER/HEATER DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 11160

    Patients

    Seq Age Sex Outcome Treatment
    1