BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8 START P HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR

    MDR report key: 6632128 · Received June 9, 2017

    Report

    Report Number
    9680841-2017-00019
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Date of Event
    April 20, 2017
    Report Date
    August 28, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. THE INSPIRE 8 START P OXYGENATOR (CATALOG NUMBER 050712, LOT 1602050162) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050712 IS SIMILAR TO THE INSPIRE 8 OXYGENATOR 050714, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). F THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED FROM DEVICE STERILIZATION AND THE DATE OF EVENT. (B)(4). PMA 510(K): THE PRODUCT ITEM 050712 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE INSPIRE 8 OXYGENATOR (050714), WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K130433). SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8 START P HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. 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 LOW OXYGEN VALUES WERE FOUND IN THE INSPIRE 8 START P HOLLOW FIBER OXYGENATOR WHEN THE PERFUSIONIST ANALYZED A BLOOD GAS PARAMETER FOLLOWING AORTIC CROSS CLAMP. THE PERFUSIONIST QUICKLY CHECKED THE ENTIRE CIRCUIT AND DECIDED TO CHANGE TO A NEW MEMBRANE OXYGENATOR. THERE WAS NO REPORT OF PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(6) MANUFACTURES THE INSPIRE 8 START P HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005, SORIN GROUP (B)(6). IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP (B)(6) (MANUFACTURER) AND LIVANOVA USA., INC. (IMPORTER). THE INVOLVED DEVICE WAS RETURNED TO SORIN GROUP (B)(6) FOR INVESTIGATION. DURING VISUAL INSPECTION, NO VISIBLE DEFECTS WERE NOTED. A GAS EXCHANGE PERFORMANCE TEST WAS CONDUCTED PER ISO 7199 STANDARD BLOOD CONDITIONS. NO DEVICE MALFUNCTION WAS BEEN IDENTIFIED DURING THIS TESTING. THE INVOLVED DEVICE WAS FOUND TO BE CONFORMING TO THE MANUFACTURER SPECIFICATIONS. AS THE ISSUE COULD NOT BE REPRODUCED, A ROOT CAUSE WAS NOT DETERMINED. HOWEVER, THE MOST LIKELY ROOT CAUSE IS ASSOCIATED TO THE CLINICAL PRACTICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411543 INSPIRE 8 START P HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA S.R.L. 1602050162

    Patients

    Seq Age Sex Outcome Treatment
    1