BEUDAMED
    FDA Adverse Event Other Summary report: N

    FR VILLEURBANNE

    MDR report key: 1942919 · Received December 22, 2010

    Report

    Report Number
    1718850-2010-00178
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    November 16, 2010
    Report Date
    November 25, 2010
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K022450
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS OCCURRED DURING PRIME. THERE WAS NO PT INVOLVED. THE EXPIRATION DATE WILL BE FORWARDED WHEN AVAILABLE. THE MFG DATE WILL BE FORWARDED WHEN AVAILABLE. SORIN GROUP (B)(4) MANUFACTURES THE SYNTHESIS OXYGENATOR. ATTACHED TO THE MEMBRANE COMPARTMENT IS AN INTEGRAL ARTERIAL FILTER. THE OXYGENATOR IS A COMPONENT OF THE CUSTOMER PERFUSION PACK. THE 510(K) NUMBER FOR THE SYNTHESIS OXYGENATOR IS K022450. THIS INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). DURING PRIME, THE PERFUSIONIST REPORTED DIFFICULTY REMOVING AIR FROM THE TOP OF THE ARTERIAL FILTER. THE PRODUCT HAS BEEN RECEIVED AT SORIN GROUP (B)(4) FOR EVAL. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE. THERE WAS NO PT INVOLVEMENT. THE FACILITY REPORTED THE EVENT TO THE COUNTRY'S COMPETENT AUTHORITY. THIS MEDWATCH IS BEING FILED AS A RESULT OF THIS ACTION. IN THE INSTRUCTIONS FOR USE STATES "REMOVE THE CLAMP FROM THE VENOUS LINE AND START WITH THE PUMP AT A REASONABLY HIGH FLOW SO THAT THE PUMP SEGMENT IS PRIMED. REDUCE THE FLOW RATE TO 100-300 CC/MIN. AS SOON AS PRIMING LIQUID REACHES THE ARTERIAL FILTER. SLOWLY FILL THE FILTER IN SUCH A WAY THAT THE AIR IS PUSHED TO THE TOP, BOTH ON THE OUTSIDE AND INSIDE OF THE SCREEN. IN ORDER TO ENCOURAGE THE FLUID TO PERMEATE THE SCREEN, STOP THE PUMP, LIGHTLY TAP THE FILTER UNTIL THE LEVELS INSIDE AND OUTSIDE THE SCREEN ARE EQUIVALENT, THEN RESTART THE PUMP AND CONTINUE PRIMING. AFTER PRIMING THE FILTER, OPEN THE ARTERIAL CLAMP AND INCREASE THE FLOW RATE TO 5-6 LITERS/MIN. PRIMING THE REST OF THE CIRCUIT.

    Description of Event or Problem · 1

    DURING PRIME, THE PERFUSIONIST COULD NOT REMOVE THE AIR AT THE TOP OF THE INTEGRAL ARTERIAL FILTER IN THE SYNTHESIS OXYGENATOR. ANOTHER OXYGENATOR WAS USED. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FR VILLEURBANNE CUSTOM PERFUSION PACK DTZ SORIN GROUP ITALIA NA 1007230054

    Patients

    Seq Age Sex Outcome Treatment
    1