BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER

    MDR report key: 6394281 · Received March 10, 2017

    Report

    Report Number
    9680841-2017-00005
    Event Type
    Malfunction
    Date Received
    March 10, 2017
    Date of Event
    February 10, 2017
    Report Date
    May 12, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER E2016005. THE INVOLVED OXYGENATOR WAS RETURNED TO SORIN GROUP (B)(4) FOR INVESTIGATION. SIMULATED USE TESTING WAS PERFORMED IN STANDARD CONDITIONS WHILE MONITORING GAS EXCHANGE PERFORMANCES. THE TESTING SHOWED THAT THE OXYGENATOR PERFORMED ACCORDING TO PRODUCT SPECIFICATIONS AND NO FAILURE COULD BE REPRODUCED. THE MANUFACTURING RECORD FOR THE INVOLVED DEVICE WAS REVIEWED AND THE OXYGENATOR WAS FOUND TO HAVE MET THE MANUFACTURER'S SPECIFICATIONS UPON RELEASE. THE REPORTED LOT HAS NOT BEEN INVOLVED IN OTHER SIMILAR COMPLAINTS. AS THE ISSUE COULD NOT BE REPRODUCED, THE ROOT CAUSE WAS NOT IDENTIFIED AND CORRECTIVE ACTIONS WERE NOT DETERMINED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINED INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE STERILE CONVENIENCE PACK IS: (B)(4). THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED FROM DEVICE STERILIZATION AND THE DATE OF EVENT. (B)(4). THE COMPLAINED INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STAND ALONE OXYGENATOR (CATALOG NUMBER 050702) IS REGISTERED IN THE USA (510(K) NUMBER: K130209). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE OXYGENATOR WAS ASSEMBLED. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005, SORIN GROUP (B)(4). IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP (B)(4) (MANUFACTURER) AND (B)(4). (IMPORTER). A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE ARTERIAL GAS (OXYGEN) LEVELS WERE LOW DURING A PROCEDURE. THE INSPIRE 6F OXYGENATOR WAS CHANGED OUT TO RESOLVE THE ISSUE. ON (B)(6) 2017, SORIN GROUP (B)(4) RECEIVED A USER MEDWATCH REPORT (MW5067887) REGARDING THIS EVENT. THE REPORT STATED THAT THE PATIENT'S VITAL SIGNS AND LEVELS REMAINED CONSTANT THROUGHOUT THE PROCEDURE AND THAT NO RESIDUAL EFFECTS OR COMPLICATIONS WERE NOTED POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176819 INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA S.R.L. 1609070141

    Patients

    Seq Age Sex Outcome Treatment
    1