BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F: HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHEL

    MDR report key: 8424330 · Received March 15, 2019

    Report

    Report Number
    9680841-2019-00011
    Event Type
    Malfunction
    Date Received
    March 15, 2019
    Date of Event
    February 1, 2019
    Report Date
    May 28, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    UDI-DI
    08033178112383
    PMA / PMN Number
    K130433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL. THE INCIDENT OCCURRED IN (B)(6). 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). THE INVOLVED DEVICE HAS BEEN RETURNED TO THE MANUFACTURER AND SUBMITTED TO GAMMA RAY DECONTAMINATION PRIOR THE INSPECTION. THE VISUAL INSPECTION FOUND NO DEFECTS NOR NON-CONFORMITIES. NO SPECIFIC CORRECTIVE ACTION HAS BEEN IDENTIFIED AT THE PRESENT DATE. LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF THE EVENT. PER EXEMPTION NUMBER E2016005. 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

    SEE INITIAL REPORT.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT DURING A PROCEDURE, A SUDDEN DROP OF BLOOD FLOW WAS OBSERVED. THE MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. ON (B)(6) 2019, LIVANOVA WAS INFORMED THAT AFTER A FEW DAYS OF INDUCED COMA, PATIENT PRESENTED LIGHT NEUROLOGICAL INJURY AND THAT THE CHANGE-OUT LASTED NEARLY 5 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218225 INSPIRE 8F: HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHEL HARDSHELL VENOUS/CARDIOTOMY RESERVOIR DTZ SORIN GROUP ITALIA SRL 8F PH.I.S.I.O. 1811160004 08033178112383

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR