BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 6755961 · Received July 31, 2017

    Report

    Report Number
    9611109-2017-00585
    Event Type
    Malfunction
    Date Received
    July 31, 2017
    Date of Event
    March 29, 2017
    Report Date
    July 31, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO KNOWN PATIENT INVOLVEMENT. RECALL NUMBER: LIVANOVA (B)(4) IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF SORIN 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). THIS EVENT WAS INITIALLY REPORTED ON A SINGLE MEDWATCH REPORT (9611109-2017-00374, SUBMITTED JUNE 2, 2017), AS THE FACILITY DID NOT SPECIFY HOW MANY DEVICES WERE CONTAMINATED. THROUGH FOLLOW-UP COMMUNICATION WITH THE CUSTOMER ON JULY 6, 2017, LIVANOVA (B)(4) LEARNED THAT ALL OF THE UNITS AT THE FACILITY HAVE TESTED POSITIVE FOR MYCOBACTERIUM CHIMAERA. THE FACILITY LATER CONFIRMED THAT THE SERIAL NUMBER SUBJECT OF THIS REPORT WAS ONE OF THE AFFECTED DEVICES. DURING PRIOR FOLLOW-UP COMMUNICATION, THE CUSTOMER REPORTED THAT THE CLEANING PROCEDURE IS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND THAT THE AFFECTED DEVICE HAS BEEN REPLACED. LIVANOVA (B)(4) HAS INITIATED A CAPA PROJECT FOR THIS TYPE OF ISSUE. AS THE CONTAMINATED DEVICE HAS BEEN REPLACED, NO FURTHER INVESTIGATION IS POSSIBLE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    ON MAY 5, 2017, LIVANOVA (B)(4) RECEIVED A USER MEDWATCH REPORT (B)(4) STATING THAT ALL OF THE DEVICES AT THE FACILITY TESTED POSITIVE FOR MYCOBACTERIUM CHIMAERA. THE DEVICES WERE SAMPLED IN RESPONSE TO A NOTIFICATION FROM THE CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) REGARDING SEVERAL CLUSTERS OF INFECTIONS LINKED TO THE HEATER-COOLER SYSTEM 3T. THE REPORT INDICATED THAT NO PATIENT INFECTIONS HAVE BEEN REPORTED AND THAT REPLACEMENT HEATER-COOLER DEVICES HAVE BEEN ORDERED. THERE IS NO KNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534616 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1