BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D903 AVANT 2 OXYGENATOR PHISIO COATED

    MDR report key: 7684668 · Received July 13, 2018

    Report

    Report Number
    9680841-2018-00019
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 12, 2018
    Report Date
    September 27, 2018
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    UDI-DI
    08033178100106
    PMA / PMN Number
    K033323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT PROVIDED. INITIAL REPORTER CONTACT PHONE NUMBER 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). SORIN GROUP (B)(4) MANUFACTURES THE D903 AVANT 2 PHYSIO COATED OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). 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. DEVICE NOT YET RETURNED.

    Additional Manufacturer Narrative · 0

    SORIN GROUP ITALIA MANUFACTURES THE D903 AVANT 2 PHISIO COATED OXYGENATOR. THE INCIDENT OCCURRED IN EDMONTON, CANADA. 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. DURING VISUAL INSPECTION, NO VISIBLE DEFECTS WERE NOTED. THE DEVICE WAS TESTED IN ORDER TO EVALUATE THE PRESSURE DROP IN STANDARD CONDITIONS. NO DEVICE MALFUNCTION WAS IDENTIFIED DURING THIS TESTING. THE DEVICE WAS FOUND TO BE CONFORMING TO MANUFACTURER SPECIFICATIONS. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. AS THE ISSUE COULD NOT BE REPRODUCED, A ROOT CAUSE WAS NOT DETERMINED. HOWEVER, ONE POSSIBLE ROOT CAUSE IS TRANSIENT UNDESIRED CELLULAR ACTIVATION. THIS ROOT CAUSE IS MULTI-FACTORIAL IN NATURE AND NOT DEVICE SPECIFIC.

    Description of Event or Problem · 0

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT TRANSMEMBRANE PRESSURE OF THE D903 AVANT 2 OXYGENATOR INCREASED DURING A PROCEDURE. DURING FOLLOW-UP COMMUNICATION WITH THE CUSTOMER ON (B)(6) 2018, SORIN GROUP (B)(4) WAS INFORMED THAT NITROPRUSSIDE WAS ADMINISTERED TO THE PATIENT. THERE WAS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529515 D903 AVANT 2 OXYGENATOR PHISIO COATED OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA D903 DIDECO AVANT 2 PHISIO 1705080145 08033178100106

    Patients

    Seq Age Sex Outcome Treatment
    1