BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATER COOLER SYSTEM 3T

    MDR report key: 5011494 · Received August 13, 2015

    Report

    Report Number
    9611109-2015-00295
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    October 15, 2014
    Report Date
    April 12, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND GMBH
    Product Code
    DWC
    PMA / PMN Number
    K052601
    Removal / Correction Number
    Z-2076/2081-2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT A PATIENT WAS INFECTED WITH (B)(6). THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE. SORIN IMPLEMENTED A FIELD SAFETY NOTICE FOR DISINFECTION AND CLEANING OF SORIN HEATER COOLER DEVICES THE Z NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    PATIENT SEX: MALE.

    Additional Manufacturer Narrative · 1

    THE SERIAL NUMBER WAS NOT PROVIDED. IT WILL BE SUBMITTED WHEN AVAILABLE. THE SERIAL NUMBER WAS NOT PROVIDED. THE MANUFACTURING DATE COULD NOT BE DETERMINED. IT WILL BE SUBMITTED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE PREVIOUS FOLLOW-UP (FOLLOW-UP #2) INDICATED AN ALERT DATE OF 7/27/2015. THE CORRECT ALERT DATE IS 7/20/2015. ON JANUARY 13TH, 2016, A RETROSPECTIVE EVALUATION IDENTIFIED THAT THIS INFORMATION HAS NOT YET BEEN PROVIDED IN A MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(6). FOUR SERIAL NUMBERS HAVE BEEN PROVIDED ((B)(4)), BUT IT IS STILL NOT KNOWN WHICH ONE IS RELATED TO THIS REPORT/PATIENT. THIS INFORMATION WILL BE PROVIDED IN A FOLLOW-UP REPORT IF AND WHEN THE INFORMATION IS MADE AVAILABLE. THE CORRECT SERIAL NUMBER FOR THIS REPORT IS UNKNOWN. THE MANUFACTURE DATES FOR ALL REPORTED SERIAL NUMBERS ARE: (B)(4): 04/13/2011, (B)(4): 04/13/2011, (B)(4): 04/13/2011, (B)(4): 11/25/2011. (B)(4). FURTHER INFORMATION ON THE PATIENT OUTCOME HAS BEEN PROVIDED. PATIENT DEVELOPED A RIGHT PLEURAL EFFUSION AND ATRIAL FIBRILLATION POST-OPERATIVELY. A BIOPSY OF THE T9/T10 VERTEBRA WAS CULTURED AND GREW INTRACELLULAR BACTERIUM. PATIENT SHOWED SOME COLLAPSE OF T9/T10, WHICH REQUIRED INTERVENTION. PATIENT HAS BEEN TREATED WITH ANTI-INFLAMMATORIES AND HAS STABILIZED. THE FACILITY HAS REPORTED 3 CASES OF MYCOBACTERIUM INFECTION IN PATIENTS, WHICH WERE EACH FILED IN SEPARATE MEDWATCH REPORTS (THIS REPORT, 9611109-2015-00337, AND 9611109-2015-00338). FOLLOW-UP COMMUNICATION WITH THE CUSTOMER HAS REVEALED THAT ONE OF THE PATIENT INFECTIONS HAS BEEN DISCOUNTED BY THE FACILITY AS NOT LINKED TO THE SORIN HEATER-COOLER SYSTEM 3T, BUT IT IS UNKNOWN AT THIS TIME WHICH PATIENT. THIS DETERMINATION WAS MADE FOR REASONS THAT ARE STILL UNKNOWN. WHEN ANY INFORMATION ON THE SPECIFIC PATIENT IS PROVIDED, A FOLLOW-UP REPORT WILL BE SENT.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE HEATER-COOLER SYSTEM 3T. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT A PATIENT WAS INFECTED WITH MYCOBACTERIA. THE PATIENT DEVELOPED A RIGHT PLEURAL EFFUSION AND ATRIAL FIBRILLATION POST-OPERATIVELY. A BIOPSY OF THE T9/T10 VERTEBRA WAS CULTURED AND GREW INTRACELLULAR BACTERIUM. THE PATIENT SHOWED SOME COLLAPSE OF T9/T10, WHICH REQUIRED INTERVENTION. THE PATIENT HAS BEEN TREATED WITH ANTI-INFLAMMATORIES AND HAS STABILIZED. THE FACILITY HAS REPORTED 3 CASES OF MYCOBACTERIUM INFECTION IN PATIENTS, WHICH WERE EACH FILED IN SEPARATE MEDWATCH REPORTS (THIS REPORT, 9611109-2015-00337, AND 9611109-2015-00338). FOLLOW-UP COMMUNICATION WITH THE CUSTOMER HAS REVEALED THAT ONE OF THE PATIENT INFECTIONS HAS BEEN DISCOUNTED BY THE FACILITY AS NOT LINKED TO THE SORIN HEATER-COOLER SYSTEM 3T, BUT IT IS UNKNOWN WHICH PATIENT. FOUR SERIAL NUMBERS HAVE ALSO BEEN PROVIDED, BUT IT IS UNKNOWN WHICH SERIAL NUMBER IS RELATED TO WHICH PATIENT CASE, AS THE HOSPITAL DOES NOT KEEP RECORDS OF THE HEATER-COOLER USED DURING A GIVEN PROCEDURE. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED TO THE FACILITY TO INSPECT ALL FOUR UNITS AT THE FACILITY. THE INSPECTION OF THE INNER AND OUTER PARTS OF THE HEATER-COOLER UNITS REVEALED RESIDUALS AND BIOFILM IN ALL UNITS IN SEVERAL LOCATIONS INCLUDING THE PUMPS AND BOTH THE PATIENT AND CARDIOPLEGIA TANKS. THE HEATER-COOLER UNITS WITH SERIAL NUMBERS (B)(4) WERE RETURNED TO SORIN GROUP (B)(4) FOR DEEP DISINFECTION AND HAVE BEEN RETURNED TO THE CUSTOMER. THE UNIT WITH SERIAL NUMBER (B)(4) WILL HAS UNDERGONE DISINFECTION AND IS AWAITING RETURN TO THE CUSTOMER. THE UNIT WITH SERIAL NUMBER (B)(4) HAS NOT YET BEEN RETURNED FOR DEEP DISINFECTION, HOWEVER THE FACILITY IS PLANNING TO SEND IT. A REVIEW OF THE DHRS DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED FAILURE. AS CORRECTIVE ACTION, FSCA 9611109-06/03/15-002-C WAS RELEASED TO REMIND OUR CUSTOMERS ABOUT THE IMPORTANCE OF ADHERING TO THE WATER MANAGEMENT AND DISINFECTION PROCEDURE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT A PATIENT WAS INFECTED WITH (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532783 HEATER COOLER SYSTEM 3T CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS DWC SORIN GROUP DEUTSCHLAND GMBH 16-02-80 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NP Other