BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPIRE 8F PHISIO OXY MODULE WITH INTEGRATED PHISIO ARTERIAL FILTER

    MDR report key: 7684656 · Received July 13, 2018

    Report

    Report Number
    9680841-2018-00020
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 13, 2018
    Report Date
    August 27, 2018
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    UDI-DI
    08033178112383
    PMA / PMN Number
    K130433
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS A MINOR INJURY WAS REPORTED BY THE CUSTOMER, THIS REPORT HAS BEEN CLASSIFIED AS AN ADVERSE EVENT. HOWEVER, THE REPORTED INJURY WAS NOT SERIOUS. (B)(6). 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)(4) MANUFACTURES THE INSPIRE 8F PHISIO OXY MODULE WITH INTEGRATED PHISIO ARTERIAL FILTER. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005, SORIN GROUP (B)(4). IS SUBMITTING THE REPORT FOR BOTH SORIN GROUP (B)(4) (MANUFACTURER) AND (B)(4). 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. DEVICE NOT YET RETURNED.

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE INSPIRE 8F PHISIO OXYGENATOR MODULE. THE INCIDENT OCCURRED IN ZURICH, SWITZERLAND. 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 WAS RETURNED TO SORIN GROUP ITALIA FOR INVESTIGATION. VISUAL INSPECTION OF THE DEVICE DID NOT IDENTIFY ANY VISIBLE DEFECTS. TO EVALUATE THE PRESSURE DROP UNDER STANDARD CONDITIONS, SIMULATED USE TESTING WAS PERFORMED. NO DEVICE MALFUNCTION WAS IDENTIFIED DURING THIS TESTING. THE DEVICE WAS FOUND TO BE CONFORMING TO THE MANUFACTURER SPECIFICATIONS. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. AS THE ISSUE WAS NOT REPRODUCED, A ROOT CAUSE WAS NOT DETERMINED. HOWEVER, BASED ON THE EVIDENCE FROM PREVIOUSLY INVESTIGATED CASES, SORIN GROUP ITALIA BELIEVES A LIKELY ROOT CAUSE OF THE INCREASED PRESSURE DROP TO BE PLATELET ADHESION AND FIBRIN LAYER DEPOSITION INSIDE THE OXYGENATOR. THE MOST PROBABLE ROOT CAUSE OF PLATELET ADHESION AND FIBRIN DEPOSITION IS MULTI-FACTORIAL AND INCLUDES THE CLINICAL PROCEDURE (E.G SURGICAL MATERIAL), THERAPIES (E.G. ANTICOAGULANT PRESCRIPTION, HEPARIN COMPOSITION AND PRIMING COMPOSITION) AND PATIENT SPECIFIC HEALTH CONDITIONS. THE EVENT DOES NOT APPEARS TO BE DEVICE-SPECIFIC. SORIN GROUP ITALIA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE TRANSMEMBRANE PRESSURE OF THE INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR INCREASED DURING A PROCEDURE. THE USER WAS ABLE TO DECREASE THE PRESSURE SLIGHTLY BY INCREASING THE BLOOD TEMPERATURE FROM 34°C TO 37°C. AFTER THE PROCEDURE, THE PATIENT REPORTEDLY EXPERIENCED HAEMATURIA AND STRONGER THAN NORMAL SYSTEMIC INFLAMMATORY RESPONSE SYNDROME. DURING FOLLOW-UP INFORMATION SORIN HAS BEEN INFORMED THAT THERE IS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528527 INSPIRE 8F PHISIO OXY MODULE WITH INTEGRATED PHISIO ARTERIAL FILTER OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA 8F PH.I.S.I.O. 1801250134 08033178112383

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other