BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL

    MDR report key: 8335073 · Received February 13, 2019

    Report

    Report Number
    9680841-2019-00004
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    December 20, 2018
    Report Date
    April 26, 2019
    Manufacturer
    SORIN GROUP ITALIA SRL
    Product Code
    DTZ
    UDI-DI
    08033178112383
    PMA / PMN Number
    K130433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    OTHER HEALTH CARE 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). SORIN GROUP (B)(6) MANUFACTURES THE INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL. THE INCIDENT OCCURRED (B)(6). PER EXEMPTION NUMBER E2016005. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(6) FOR INVESTIGATION. 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 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL. THE INCIDENT OCCURRED IN TARTU, ESTONIA. 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. BIOLOGICAL TRACES MAINLY COMPOSED BY RED DEPOSITS, LIKELY DUE TO FIBRIN DEPOSITION AND RED BLOOD CELLS, WERE VISIBLE IN THE ARTERIAL FILTER. THE REVIEW OF THE DEVICE HISTORY RECORD OF THE CLAIMED OXYGENATOR LOT CONFIRMED THAT THE DEVICE WAS RELEASED IN COMPLIANCE WITH MANUFACTURER SPECIFICATIONS. TO SUBMIT THE DEVICE TO TEST FOR TRANSMEMBRANE PRESSURE VERIFICATION, THE DEVICE WAS EXTENSIVELY RINSED. HOWEVER, IT WAS NOT POSSIBLE TO REMOVE MOST OF BIOLOGICAL TRACES. THE TEST REPRODUCED THE CLAIMED ISSUE, THE PRESSURE DROP VALUES MEASURED DURING OUR LABORATORY TEST WERE ABOVE DEVICE SPECIFICATIONS. BASED ON MEDICAL LITERATURE, IT CAN BE CONFIRMED THAT THE INCREASE OF PRESSURE DROP HAS BEEN ASSOCIATED WITH PLATELET ADHESION AND FIBRIN LAYER DEPOSITION INSIDE THE OXYGENATOR. THE MOST PROBABLE ROOT CAUSE OF PLATELET ADHESION AND FIBRIN DEPOSITION IS MULTI-FACTORIAL AND INCLUDE CLINICAL PROCEDURE (E.G SURGICAL MATERIAL), THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT SPECIFIC HEALTH CONDITIONS. ACCORDING TO SIMILAR CASES PREVIOUSLY INVESTIGATED THE ORIGIN OF THE ACTIVATION AND INTERACTION APPEAR TO BE MULTI-FACTORIAL IN NATURE AND NOT DEVICE SPECIFIC. FOR THIS REASON, NO SPECIFIC CORRECTIVE ACTION HAS BEEN IDENTIFIED AT THE PRESENT DATE. LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    SORIN GROUP (B)(6) HAS RECEIVED A REPORT THAT, 10 MINUTES AFTER THE BEGINNING OF A PROCEDURE, THE DELTA TRANS-MEMBRANE PRESSURE OF THE INSPIRE 8F OXYGENATOR ROSE TO 300 MMHG. THE MEDICAL TEAM ELECTED TO CHANGE-OUT RESERVOIR, OXYGENATOR AND EQUIPMENT. THE PROCEDURE WAS COMPLETED WITH NO ISSUE. THERE IS NO REPORT OF ANY PATIENT INJURY. ON (B)(6) 2019, SORIN GROUP (B)(6) HAS BEEN INFORMED THE CHANGE-OUT TOOK 5 MINUTES.

    Description of Event or Problem · 0

    SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128262 INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CAR DTZ SORIN GROUP ITALIA SRL 8F PH.I.S.I.O. 1810080097 08033178112383

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR