BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 6353198 · Received February 23, 2017

    Report

    Report Number
    9611109-2017-00099
    Event Type
    Malfunction
    Date Received
    February 23, 2017
    Report Date
    January 5, 2018
    Manufacturer
    LIVANOVA DEUTSCHLAND
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO KNOWN PATIENT INVOLVEMENT. THE EVENT DATE HAS NOT BEEN PROVIDED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. THE SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. 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). MFG DATE: AS THE SERIAL NUMBER WAS NOT PROVIDED, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF AND WHEN MADE AVAILABLE. RECALL NUMBER: LIVANOVA IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF LIVANOVA 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). LIVANOVA HAS REQUESTED INFORMATION ON THE SERIAL NUMBER, DEVICE STATUS AND ANY POTENTIALLY AFFECTED PATIENTS. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED AT THIS TIME. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE MODEL NUMBER PROVIDED IN THE INITIAL REPORT WAS INCORRECT. THE CORRECT MODEL NUMBER IS 16-02-50. THE SERIAL NUMBER OF THE DEVICE WAS PROVIDED: (B)(4). THE HEATER-COOLER 16-02-50 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). SINCE THE SERIAL NUMBER WAS PROVIDED, THE DEVICE MANUFACTURE DATE COULD BE DETERMINED: 10.05.2006. LIVANOVA (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THE LAB TEST REPORT CONFIRMING THE CONTAMINATION WITH M.CHIMAERA WAS PROVIDED. FROM A FOLLOW-UP COMMUNICATION, LIVANOVA (B)(4) LEARNED THAT THE MAINTENANCE PROTOCOL IN USE WAS THE ONE WHICH WAS RECOMMENDED BY LIVANOVA (B)(4), AND THAT THE DEVICE WAS POSITIONED WITHIN THE OPERATION THEATER DURING USE. IT WAS STATED FURTHERMORE THAT THE AIR EXHAUST WAS DIRECTED TO THE OPPOSITE SIDE OF THE OPERATION THEATRE WITH AN ESTIMATED DISTANCE OF APPROXIMATELY 1,5 - 2 METERS TO THE SURGERY FIELD. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. CORRECTIVE ACTIONS ARE IN PROGRESS FOR THIS TYPE OF ISSUE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    LIVANOVA (B)(4) RECEIVED A REPORT THAT THE HEATER-COOLER SYSTEM 3T TESTED POSITIVE FOR MYCOBACTERIUM CHIMAERA. THERE IS NO KNOWN PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135129 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND 16-02-50

    Patients

    Seq Age Sex Outcome Treatment
    1