BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 6F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER & HARDSHELL RES

    MDR report key: 7497680 · Received May 9, 2018

    Report

    Report Number
    9680841-2018-00013
    Event Type
    Malfunction
    Date Received
    May 9, 2018
    Date of Event
    April 11, 2018
    Report Date
    July 10, 2018
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DTZ
    UDI-DI
    08033178112277
    PMA / PMN Number
    K130209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF THE EVENT. (B)(4). PER EXEMPTION NUMBER E2016005. OXYGENATOR WAS RETURNED AND INVESTIGATION OF THE UNIT HAS BEEN PLANNED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 6F HOLLOW FIBER OXYGENATOR. THE INCIDENT OCCURRED IN NIEUWEGEIN, NETHERLANDS. PER EXEMPTION NUMBER E2016005, SORIN GROUP ITALIA S.R.L. IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP ITALIA S.R.L (MANUFACTURER) AND LIVANOVA USA., INC. (IMPORTER). VISUAL INSPECTION OF THE RETURNED UNIT CONFIRMED THAT THE CORONARIC VALVE WAS DISCONNECTED FROM THE BODY OF THE OXYGENATOR IN THE POINT WHERE THE VALVE IS GLUED TO THE OXYGENATOR. THE INVESTIGATION CONFIRMED THAT THE VALVE SUB-ASSEMBLY WAS NOT PROPERLY BONDED TO ITS SEAT ON THE OXYGENATOR BODY. SORIN GROUP ITALIA DETERMINED THAT THE MOST LIKELY ROOT CAUSED WAS DUE TO A MALFUNCTION OF THE GLUING DISPENSER. TO AVOID RECURRENCE, DOSING PARAMETERS AND POSITIONING OF COMPONENTS TO BE GLUED IN THE GLUING DISPENSER WERE OPTIMIZED AND AN ADDITIONAL VISUAL INSPECTION WAS IMPLEMENTED. A REVIEW OF THE DHR REVEALED THAT THE UNIT SUCCESSFULLY PASSED THE IN-PROCESS LEAK TEST, AND A COMPLAINT HISTORY REVIEW FOR THIS TYPE OF ISSUE FOUND THAT IT HAS ONLY OCCURRED ON TWO UNITS OVER THE PAST THREE YEARS. THIS MDR HAS BEEN ALREADY SUBMITTED JULY 10, 2018 AND RESUBMITTED DUE TO MISSING 3RD ACKNOWLEDGMENT.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE CARDIOPLEGIA CONNECTOR WAS DISCOVERED TO BE DETACHED FROM THE BODY OF THE INSPIRE 6F HOLLOW FIBER OXYGENATOR DURING SET UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341358 INSPIRE 6F HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER & HARDSHELL RES HOLLOW FIBER OXY W/ INTEGRATED ARTERIAL FILTER & HARDSHELL VENOUS/CARDIOTOMY RES DTZ SORIN GROUP ITALIA S.R.L. 6F M 1711220233 08033178112277

    Patients

    Seq Age Sex Outcome Treatment
    1