BEUDAMED
    FDA Adverse Event Other Summary report: N

    RU NOVOSIBIRSK

    MDR report key: 3430314 · Received October 16, 2013

    Report

    Report Number
    1718850-2013-00216
    Event Type
    Other
    Date Received
    October 16, 2013
    Report Date
    September 17, 2013
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DWF
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE CUSTOM PERFUSION PACK LISTED ABOVE. THIS PACK IS NOT SOLD IN THE UNITED STATES AND THEREFORE HAS NO 510 (K) NUMBER. THE D100 DIDECO KIDS OXYGENATOR IS A COMPONENT OF THE CUSTOMER PERFUSION PACK. THE 510 (K) NUMBER FOR THE OXYGENATOR IS K061031. 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 A CRACK IN THE OUTLET PORT OF THE D100 DIDECO KIDS OXYGENATOR DURING A PROCEDURE. THE OXYGENATOR WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO REPORT OF PT INJURY. 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 DIDECO KIDS OXYGENATOR DURING A PROCEDURE. THE OXYGENATOR WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531055 RU NOVOSIBIRSK CUSTOM PERFUSION PACK DWF SORIN GROUP ITALIA NA 130122081

    Patients

    Seq Age Sex Outcome Treatment
    1 NP