BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES

    MDR report key: 7406992 · Received April 9, 2018

    Report

    Report Number
    9680841-2018-00007
    Event Type
    Malfunction
    Date Received
    April 9, 2018
    Date of Event
    November 26, 2017
    Report Date
    April 11, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINED INSPIRE 8 START OXYGENATOR (CATALOG NUMBER 050710, LOT 1706140040) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050710 IS SIMILAR TO THE INSPIRE 8 OXYGENATOR 050714, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF THE EVENT. (B)(4). THE PRODUCT ITEM 050710 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). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8 START HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. THE INVOLVED OXYGENATOR AND THE CIRCUIT INTO WHICH THE OXYGENATOR WAS ASSEMBLED WERE NOT MADE AVAILABLE FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. A PHYSICAL INVESTIGATION OF THE UNIT COULD NOT BE PERFORMED. THE PUMP SHEET FOR THE CASE WAS ALSO NOT PROVIDED. DUE TO THE LIMITED INFORMATION PROVIDED AND THE INABILITY TO PERFORM AN EVALUATION OF THE INVOLVED DEVICE, A ROOT CAUSE COULD NOT BE DETERMINED. THE CONNECTION THAT REPORTEDLY DISCONNECTED IS NOT PART OF A SORIN PRE-CONNECTED CIRCUIT. THE OXYGENATOR WAS MANUFACTURED, TESTED AND RELEASED IN COMPLIANCE WITH STANDARD MANUFACTURING PROCEDURES. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE MEDICAL TEAM EXPERIENCED DIFFICULTY WITH MAINTAINING FULL BLOOD FLOW DUE TO HIGH A TRANS-MEMBRANE PRESSURE IN THE INSPIRE 8 START HOLLOW FIBER OXYGENATOR A FEW MINUTES AFTER GOING ONTO BYPASS. THE REPORT INDICATED THAT THE TUBING SUDDENLY DISCONNECTED FROM THE ARTERIAL OUTLET OF THE OXYGENATOR AND THE OXYGENATOR MODULE HAD TO BE REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. DURING FOLLOW UP COMMUNICATION ON (B)(6) 2018, IT WAS LEARNED THAT THE CHANGE OUT OF THE OXYGENATOR TOOK MORE THAN THREE MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251653 INSPIRE 8 HOLLOW FIBER OXYGENATOR W/ INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RES OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA S.R.L. 1706140040

    Patients

    Seq Age Sex Outcome Treatment
    1 Other