BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 6368763 · Received March 1, 2017

    Report

    Report Number
    9611109-2017-00122
    Event Type
    Malfunction
    Date Received
    March 1, 2017
    Date of Event
    January 17, 2017
    Report Date
    September 7, 2017
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    PMA / PMN Number
    K052601
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL CLEANING WAS PERFORMED BEFORE FIRST TESTING. TESTING WAS COMPLETED ON PATIENT DRAIN AND CARDIOPLEGIA DRAIN SIDES. INITIAL INSPECTION SAMPLING RESULTS ON (B)(6) 2016 AND (B)(6) 2016 INDICATED HETEROTROPHIC PLATE COUNT (HTP) COUNTS LESS THAN 2; HOWEVER, A WATER SAMPLE TAKEN AFTER 3 DAYS IN SERVICE INDICATE A HTP COUNT ON (B)(6) 2016 DISPLAY RESULTS GREATER THAN 500. TESTING ON (B)(6) 2016, AFTER WATER CHANGE, CONCLUDED A HTP COUNT OF 2. A SAMPLE TAKEN AFTER ONE CASE ON (B)(6) 2016 SHOWED A HTP COUNT OF 60. THE DEVICE IS STILL IN USE. THROUGH FOLLOW-UP COMMUNICATION, LIVANOVA (B)(4) LEARNED THAT THE WATER IS FILTERED THROUGH THE PALL RECOMMENDED FILTER. ADDITIONALLY, FILTERS ARE BEING CHANGED AS RECOMMENDED AND WERE BEING CHANGED DAILY. A RETROFIT UPGRADE IS SCHEDULED BEFORE THE END OF SEPTEMBER. AT THAT TIME, FOLLOW-UP WILL BE INITIATED TO ASCERTAIN IF THE SITE IS STILL DISINFECTING THE DEVICE PER INSTRUCTIONS FOR USE, TO OBTAIN INFORMATION REGARDING THE FREQUENCY OF WATER CHANGE, AND ALSO OBTAIN AN UPDATE ON THEIR TEST RESULTS.

    Additional Manufacturer Narrative · 1

    LIVANOVA IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF HEATER-COOLER DEVICES. THE Z NUMBER IS Z-2076/2081-2015. LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). THE CUSTOMER PROVIDED THE TEST REPORT TO LIVANOVA (B)(4), WHICH SHOWS A HETEROTROPHIC PLATE COUNT OF 142 CFU/ML. REVIEW OF THE FINAL TEST RESULTS TAKEN BY LIVANOVA (B)(4) UPON COMPLETION OF THE DEEP DISINFECTION PROCEDURE FOUND THAT THE DEVICE SHOWED NO CONTAMINATION (0 CFU/ML) ON SEPTEMBER 5, 2016 BEFORE BEING RETURNED TO THE FACILITY. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVESTIGATION IS ON-GOING. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE MICROBIOLOGY RESULTS FOR THE HEATER-COOLER SYSTEM 3T SHOWED THAT THE BACTERIAL LEVELS (HETEROTROPHIC PLATE COUNT) WERE OUTSIDE THE RECOMMENDED LIMITS DURING MAINTENANCE. THE CUSTOMER REPORTED THAT THE HEATER COOLER SYSTEM 3T HAD RECENTLY BEEN RETURNED TO THE HOSPITAL AFTER UNDERGOING DEEP DISINFECTION AT LIVANOVA (B)(4) A FEW WEEKS PRIOR. THE CUSTOMER ALSO STATED THAT THE UPDATED DISINFECTION PROTOCOL IS BEING FOLLOWED AND DAILY WATER CHANGES ARE PERFORMED IN ORDER TO KEEP THE MICROBIOLOGY LEVELS WITHIN THE LIMITS. THERE IS NO KNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153358 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1