BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 8548734 · Received April 25, 2019

    Report

    Report Number
    9611109-2019-00281
    Event Type
    Malfunction
    Date Received
    April 25, 2019
    Report Date
    January 28, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.10: THE DEVICE WAS SENT TO LIVANOVA FOR DEEP DISINFECTION ON APRIL 16, 2019. ON MAY 21, 2019 LABORATORY TESTS CONDUCTED BEFORE DEEP DISINFECTION (PRE-DD) DID NOT CONFIRM THE REPORTED CONTAMINATION. AS PER THE INSTRUCTION FOR USE CP_IFU_16-XX-XX_ENG CHAPTER 6.3.3 MONITORING THE WATER QUALITY, THE TOTAL BACTERIA COUNT MUST NOT EXCEED THE LIMIT OF 100 CFU/ML. PRE-DD TESTS RESULTED TO BE WITHIN SPECIFICATIONS. THUS, THE REPORTED CONTAMINATION IS NOT CONFIRMED. BASED ON THE ABOVE MENTIONED EVIDENCES, IT IS LIKELY THAT A CONTAMINATION OF THE SAMPLES OCCURRED. AS PER THE INSTRUCTION FOR USE IT IS RECOMMENDED TO PAY ATTENTION TO HYGIENE MEASURE TO AVOID POTENTIAL CONTAMINATION OF THE SAMPLES.

    Description of Event or Problem · 0

    SEE INITIAL.

    Additional Manufacturer Narrative · 1

    THERE WAS NO KNOWN PATIENT INVOLVEMENT. PMA/510(K): THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K052601). RECALL NUMBER: LIVANOVA (B)(4) 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). THROUGH FOLLOW UP COMMUNICATION, LIVANOVA (B)(4) LEARNED THAT THE UNIT WAS CLEANED PER THE IFU BY ONE OF OUR TECHNICIANS. FURTHERMORE, THAT THE DEVICE IS PLACED INSIDE THE OPERATION THEATER, WITH THE FAN OF THE DEVICE POSITIONED OPPOSITE TO THE PATIENT, WITH A DISTANCE BETWEEN THE SURGERY FIELD AND THE DEVICE OF 2 METERS. THE DEVICE IS FULLY FUNCTIONAL. A REVIEW OF THE DHR COULD NOT IDENTIFY ANY DEVIATIONS OR NONCONFORMITIES RELEVANT TO THE ISSUE. CORRECTIVE ACTIONS ARE IN PROGRESS FOR THIS ISSUE. 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 A HEATER-COOLER SYSTEM 3T WAS FOUND TO BE CONTAMINATED WITH PSEUDOMONAS AERUGINOSA AND OCHROBACTRUM ANTHROPI. THE LAB REPORT HAS BEEN SUPPLIED, TESTING PERFORMED AS CULTURE IN LIQUID MEDIUM. THERE IS NO KNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344951 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-80

    Patients

    Seq Age Sex Outcome Treatment
    1