BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CP840442 DE LEIPZIG

    MDR report key: 1692536 · Received May 12, 2010

    Report

    Report Number
    1718850-2010-00089
    Event Type
    Malfunction
    Date Received
    May 12, 2010
    Date of Event
    April 6, 2010
    Report Date
    April 16, 2010
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    DTZ
    PMA / PMN Number
    K043323
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE (B)(4) OXYGENATOR AND IT IS A COMPONENT OF THEIR HEART LUNG TUBING SET (B)(4). THE 510 (K) NUMBER IS K043323. THE INCIDENT OCCURRED AT (B)(4). THIS REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING TEAR DOWN, THE CLINICIAN NOTED BLOOD IN THE HEATER/COOLER WATER LINES AS THEY WERE REMOVED FROM THE OXYGENATOR. THERE WAS NO REPORT OF PT INJURY. PT IS FINE. SORIN GROUP(B)(4) HAS RECEIVED THE OXYGENATOR FOR EVAL. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT DURING TEAR DOWN, THE CLINICIAN NOTED BLOOD IN THE HEATER/COOLER WATER LINES AS THEY WERE REMOVED FROM THE OXYGENATOR. THERE WAS NO REPORT OF PT INJURY. PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CP840442 DE LEIPZIG TUBING SET HEART LUNG BYPASS DTZ SORIN GROUP ITALIA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1