BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    D905 EOS PHISIO OXYGENATOR

    MDR report key: 6773064 · Received August 8, 2017

    Report

    Report Number
    9680841-2017-00021
    Event Type
    Malfunction
    Date Received
    August 8, 2017
    Date of Event
    July 7, 2017
    Report Date
    October 18, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L.
    Product Code
    DTZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE D905 EOS PHISIO OXYGENATOR (CATALOG NUMBER 050512, LOT 1612190034) IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE OXYGENATOR ITEM 050512 IS SIMILAR TO THE D905 EOS PHISIO OXYGENATOR 050510, WHICH IS DISTRIBUTED IN THE USA, FOR WHICH THE DEVICE IDENTIFIER IS (B)(4). INITIAL REPORTER TELEPHONE NUMBER: (B)(6). THE AGE OF THE DEVICE WAS CALCULATED AS THE TIME ELAPSED FROM DEVICE STERILIZATION AND THE DATE OF EVENT. (B)(4). THE PRODUCT ITEM 050512 IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE D905 EOS PHISIO HOLLOW FIBER OXYGENATOR (050510), WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K043323). SORIN GROUP (B)(4) MANUFACTURES THE D905 EOS PHISIO OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. THE INVOLVED DEVICE HAS BEEN RETURNED 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

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT AN INCREASE OF THE PRE-MEMBRANE PRESSURE OF THE WITH D905 EOS PHISIO OXYGENATOR WAS OBSERVED DURING A CARDIOPULMONARY BYPASS PROCEDURE. THE CUSTOMER REPORTED THAT THE PRESSURE SLOWLY ROSE THROUGH THE CASE. THE PATIENT WAS GIVEN NIPRIDE TO REDUCE THE PRESSURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE D905 EOS PHISIO OXYGENATOR. THE INCIDENT OCCURRED IN (B)(6). PER EXEMPTION NUMBER E2016005, (B)(4). THE INVOLVED DEVICE WAS RETURNED TO SORIN GROUP (B)(4) 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, A POSSIBLE ROOT CAUSE IS TRANSIENT UNDESIRED CELLULAR ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553907 D905 EOS PHISIO OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA S.R.L. 1612190034

    Patients

    Seq Age Sex Outcome Treatment
    1