BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL COOLER/HEATER

    MDR report key: 4340143 · Received December 9, 2014

    Report

    Report Number
    1828100-2014-01040
    Event Type
    Malfunction
    Date Received
    December 9, 2014
    Date of Event
    November 12, 2014
    Report Date
    May 12, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP
    Product Code
    DWC
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE SCRIPT QUESTION FOLLOW-UP WITH THE CUSTOMER: THE CUSTOMER'S PREVENTIVE MAINTENANCE (PM) SCHEDULE ON THE COOLER HEATER UNIT IS EVERY SIX MONTHS. THEY RUN THE DEVICE AT THE SET TEMPERATURE POINTS, COMPARE TEMPERATURES ON GAUGE TO OUR FLUKE DIGITAL TEMPERATURE METER, AND CLEAN THE WATER BUCKET OF ALGAE AND DEBRIS. THE CUSTOMER DOES NOT HAVE A CHLORINE MAINTENANCE SCHEDULE. THE MANUFACTURER PROVIDES ESTABLISHED REQUIREMENTS FOR SANITIZATION AND INSTRUCTIONS FOR CORRECTLY MAINTAINING THE SYSTEM. THESE ARE CLEARLY OUTLINED IN THE DUAL COOLER HEATER (DCH) OPERATORS MANUAL AND DCH CLEANING GUIDE. INCLUDED IN THE REQUIREMENTS IS A DAILY SANITIZATION PROCEDURE WITH A CHECK OF THE CHLORINE LEVELS, WEEKLY CLEANING AND SANITIZATION AND A SEMIANNUAL DESCALING PROCEDURE. DECONTAMINATION IS REQUIRED WHENEVER BIOFILM IS EVIDENT IN THE SYSTEM (DISCOLORATION OR CLOUDINESS IN THE WATER SYSTEM). IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS NOT VERIFIABLE. DILIGENCE ATTEMPTS TO GET INFO ABOUT THE REPAIR AND EQUIPMENT STATUS WERE NOT SUCCESSFUL. NO PRODUCT WAS RETURNED TO THE MANUFACTURER FOR EVAL. NO ADD'L ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY'S BIOMEDICAL ENGINEER (BIOMED) WILL BE MAKING THE NECESSARY REPAIRS TO THE COOLER HEATER UNIT.

    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 NOT HEATING. AS A RESULT, AN ALTERNATE DEVICE WAS EMPLOYED. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY, NO BLOOD LOSS, NOR ADVERSE CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792986 DUAL COOLER/HEATER SARNS DUAL COOLER/HEATER DWC TERUMO CARDIOVASCULAR SYSTEMS CORP 11160

    Patients

    Seq Age Sex Outcome Treatment
    1