BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D905 EOS OXYGENATOR (PHISIO TREATED)

    MDR report key: 7684671 · Received July 13, 2018

    Report

    Report Number
    9680841-2018-00021
    Event Type
    Malfunction
    Date Received
    July 13, 2018
    Date of Event
    June 2, 2018
    Report Date
    September 28, 2018
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINED D905 DIDECO EOS PHISIO (CATALOG NUMBER 050512, LOT 1704140014) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE COMPLAINED OXYGENATOR IS SIMILAR TO THE D905 DIDECO EOS PHISIO/M OXYGENATOR 050510, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). INITIAL REPORTER CONTACT PHONE NUMBER IS: (B)(6). THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED BETWEEN DEVICE STERILIZATION AND THE DATE OF THE EVENT. (B)(4). THE PRODUCT ITEM 050512 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE D905 DIDECO EOS PHISIO/M OXYGENATOR ITEM 050510, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K043323). THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED OXYGENATOR. SORIN GROUP (B)(4) MANUFACTURES THE INSPIRE 8F M HOLLOW FIBER 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 OBTAINED, 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 REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. HOWEVER, THE UNIT WAS NEVER MADE AVAILABLE AND AN EVALUATION COULD NOT BE PERFORMED. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. BASED ON SIMILARITY TO PREVIOUSLY INVESTIGATED CASES, A POSSIBLE ROOT CAUSE IS TRANSIENT UNDESIRED CELLULAR ACTIVATION, WHICH 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 D905 EOS 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 AND A HETEROLOGOUS BLOOD TRANSFER WAS PERFORMED. THERE WAS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529517 D905 EOS OXYGENATOR (PHISIO TREATED) OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA 1704140014

    Patients

    Seq Age Sex Outcome Treatment
    1