BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARNS TCM II HEATING AND COOLING SYSTEM

    MDR report key: 5554175 · Received April 7, 2016

    Report

    Report Number
    1828100-2016-00236
    Event Type
    Malfunction
    Date Received
    April 7, 2016
    Report Date
    May 13, 2016
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DWC
    PMA / PMN Number
    K883603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE BIOMED: I WANTED TO LET SOMEONE KNOW THAT ONE OF OUR COOLER HEATER UNITS (THIS ONE COINCIDENTLY) CAME BACK POSITIVE FOR NTM CHIMAERA. WE DO NOT HAVE ANY ASSOCIATED INFECTIONS OF THIS TYPE AND NO CONNECTION TO THIS COOLER HEATER. THIS UNIT IS CURRENTLY NOT GOING TO BE UTILIZED IN PATIENT CARE UNTIL WE GET THE RESULTS BACK FROM A REPEAT TEST AND ONLY THEN IF IT IS NEGATIVE. WE FOLLOW/EXCEED RECOMMENDED CLEANING PROCEDURES.

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS NOT CONFIRMED. ON 04-MAY-2016, CLINICAL SERVICES RECEIVED FOLLOW UP FROM THE PERFUSIONIST (CCP). THE REPEAT CULTURE OF WATER IN THE HEATER/COOLER CAME BACK NEGATIVE FOR NONTUBERCULOUS MYCOBACTERIA (NTM) CHIMAERA BACTERIA. THE UNIT WILL BE PLACED BACK IN CLINICAL SERVICE. THE USER FACILITY HAS ELECTED TO CULTURE THEIR THREE HEATER/COOLER UNITS PERIODICALLY TO CHECK FOR THE PRESENCE OF NTM BACTERIA. NO PATIENT HAS BEEN DIAGNOSED WITH AN NTM INFECTION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    PER THE CLINICAL REVIEW ON 31-MAR-2016: THE MANUFACTURER'S CLINICAL SERVICES (CS) SPOKE TO THE USER FACILITY PERFUSIONIST (CCP) ON (B)(6) 2016 IN REGARDS TO THIS ISSUE. (B)(4) CS ASKED THE CCP TO DESCRIBE THEIR ROUTINE PRACTICE FOR CLEANING AND DISINFECTION OF THEIR COOLER HEATER UNITS. (B)(4). ACCORDING TO THE CCP, THIS UNIT HAS BEEN USED REGULARLY IN CLINICAL SERVICE (NOT STORED FOR LONG PERIODS) PRIOR TO THE (B)(6) CULTURE TEST. AFTER THE FIRST (B)(6) CULTURE TEST, THE UNIT WAS DRAINED AND RE-FILLED WITH NEW STERILE WATER AND NORMAL CLEANING AND STERILIZATION PROCEDURES WERE DONE. A SECOND CULTURE TEST HAS BEEN DONE, AND AS OF (B)(6) 2016, THE RESULTS HAVE NOT BEEN REPORTED BY THE TEST LAB. THIS UNIT CONTINUES TO BE OUT OF CLINICAL SERVICE. ACCORDING TO THE CCP, NO PATIENT INFECTIONS HAVE BEEN LINKED TO USAGE OF THIS COOLER HEATER UNIT OR USE OF THE OTHER TWO COOLER HEATER UNITS AT THE HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE COOLER HEATER UNIT CAME BACK POSITIVE FOR NONTUBERCULOUS MYCOBACTERIA (NTM) CHIMAERA. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211935 SARNS TCM II HEATING AND COOLING SYSTEM CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS-SARNS TCM II HEATING AND COOLING DWC TERUMO CARDIOVASCULAR SYSTEMS CORP. 4415

    Patients

    Seq Age Sex Outcome Treatment
    1