BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER-COOLER SYSTEM 3T

    MDR report key: 10157656 · Received June 16, 2020

    Report

    Report Number
    9611109-2020-00353
    Event Type
    Injury
    Date Received
    June 16, 2020
    Report Date
    June 16, 2020
    Manufacturer
    LIVANOVA DEUTSCHLAND GMBH
    Product Code
    DWC
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. SERIAL NUMBER IS UNKNOWN. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. AS THE SERIAL NUMBER IS UNKNOWN, THE DEVICE MANUFACTURE DATE COULD NOT BE DETERMINED. THIS INFORMATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT IF MADE AVAILABLE. THE HEATER-COOLER 16-02-80 IS NOT DISTRIBUTED IN THE USA, AND IT IS SIMILAR TO HEATER-COOLER 16-02-85, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K191402). 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). 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

    THROUGH LITERATURE REVIEW LIVANOVA LEARNED ABOUT A (B)(6) YEARS OLD MALE PATIENT INFECTED WITH MYCOBACTERIUM CHIMAERA. HE UNDERWENT PLACEMENT OF A HEARTMATE II LVAD VIA MEDIAN STERNOTOMY WITH NORMOTHERMIC CARDIOPULMONARY BYPASS. HE REQUIRED DEVICE EXCHANGE 4 YEARS LATER FOR PUMP STOPPAGE DUE TO ELECTRICAL FAILURE, AND THIS WAS PERFORMED VIA REDO-STERNOTOMY WITH NORMOTHERMIC CARDIOPULMONARY BYPASS. ONE YEAR LATER HE PRESENTED WITH A RIGHT-SIDED ABDOMINAL WALL FLUID COLLECTION CONTIGUOUS WITH THE INTERNAL DRIVELINE TUNNEL. THE FLUID WAS DRAINED PERCUTANEOUSLY AND ACID-FAST BACILLI WERE NOTED ON MICROSCOPY. TREATMENT WITH AZITHROMYCIN, ETHAMBUTOL, AND RIFAMPIN WAS INITIATED AND MYCOBACTERIAL CULTURE WAS POSITIVE FOR M. CHIMAERA. DEBRIDEMENT AND A DELAYED FLAP COVERAGE OF EXPOSED HARDWARE WAS PERFORMED. WITHIN SEVERAL WEEKS OF THE PROCEDURE, THE PATIENT DEVELOPED ABDOMINAL WALL CELLULITIS AND WOUND DRAINAGE, REQUIRING INCISION AND DRAINAGE AND TREATMENT WITH ADDITIONAL BROAD SPECTRUM ANTIBIOTICS. HE IS FOLLOWED AS AN OUTPATIENT, NOW 3 MONTHS AFTER PRESENTING WITH THE M. CHIMAERA DEVICE-RELATED INFECTION. THE DATE OF SURGERY IS BETWEEN 2011 AND 2016 AND A HEATER-COOLER 3T DEVICE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620919 HEATER-COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC LIVANOVA DEUTSCHLAND GMBH 16-02-85

    Patients

    Seq Age Sex Outcome Treatment
    1 Other