BEUDAMED
    FDA Adverse Event Other Summary report: N

    RU NOVOSIBIRSK

    MDR report key: 3430312 · Received October 16, 2013

    Report

    Report Number
    1718850-2013-00217
    Event Type
    Other
    Date Received
    October 16, 2013
    Report Date
    September 17, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SORIN GROUP (B)(4) MANUFACTURES THE D 100 L001 PH.I.S.I.O. NEWBORN HOLLOW FIBER OXYGENATOR WITH HARDSHELL CARDIOTOMY/VENOUS RESERVOIR, WHICH IS A COMPONENT OF THE CUSTOMER PERFUSION PACK. THE 510 (K) NUMBER OF THE OXYGENATOR IS K061031. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). IT WAS REPORTED THAT THE PT WAS GIVEN ADDITIONAL BLOOD PRODUCTS AS A RESULT OF THE LEAK. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT OF BLOOD LEAKING FROM A CRACK IN THE OUTLET PORT OF THE D100 OXYGENATOR DURING A PROCEDURE. THE CLINICIAN REPLACED THE OXYGENATOR AND COMPLETED THE PROCEDURE WITHOUT ANY FURTHER ISSUES. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529541 RU NOVOSIBIRSK CUSTOMER PERFUSION PACK DTZ SORIN GROUP ITALIA NA 1301220081

    Patients

    Seq Age Sex Outcome Treatment
    1 NP