BEUDAMED
    FDA Adverse Event Other Summary report: N

    LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.), INFANT

    MDR report key: 3190416 · Received June 19, 2013

    Report

    Report Number
    1718850-2013-00099
    Event Type
    Other
    Date Received
    June 19, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 22, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K001021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. SORIN GROUP (B)(4) MANUFACTURES THE LILLIPUT PHISIO INFANT HOLLOW FIBER OXYGENATOR MODEL D902. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT OF BLOOD LEAKING FROM THE OXYGENATOR DURING THE PROCEDURE. THE OXYGENATOR WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. THERE WAS NO REPORT OF PATIENT INJURY. IT WAS ALSO REPORTED THAT THE REPLACEMENT OF THE OXYGENATOR TOOK APPROXIMATELY 5 MINUTES. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THE EXTENDED INTERRUPTION OF BYPASS. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT OF BLOOD LEAKING FROM THE OXYGENATOR DURING THE PROCEDURE. THE OXYGENATOR WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279101 LILLIPUT PHOSPHOLYPIDIC INERT SURFACE IN OXYGENATION (PH.I.S.I.O.), INFANT OXYGENATOR, CARDIOPULMONARY BYPASS DTZ SORIN GROUP ITALIA NA 1105030067

    Patients

    Seq Age Sex Outcome Treatment
    1 NP