BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOVALUNG

    MDR report key: 2464277 · Received February 8, 2012

    Report

    Report Number
    2464277
    Event Type
    Injury
    Date Received
    February 8, 2012
    Date of Event
    January 31, 2012
    Report Date
    February 2, 2012
    Manufacturer
    NOVALUNG GMBH
    Product Code
    DTZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT ON NOVALUNG DEVICE, WAS SITTING UP IN BED AND RECOGNIZED A "WET" FEELING AND REPORTED THIS TO HIS MOTHER. MOTHER CALLED NURSE WHO WAS RIGHT OUTSIDE THE ROOM AND TOLD HER HE'S BLEEDING. NURSE RESPONDED IMMEDIATELY. RED CAP NOTICED TO BE DISCONNECTED AT CRRT CONNECTION SITE AND IN POOL OF BLOOD. NURSE CLAMPED DEVICE AS INSTRUCTED AND CALLED CODE WHICH WAS RESPONDED TO IMMEDIATELY. NURSE NOTED THAT THE TWO ROBERTS CLAMPS DID NOT STOP THE FLOW OF BLOOD WHEN SHE CLAMPED THEM CLOSED; REQUIRED USE OF SURGICAL HEMOSTATS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOVALUNG SLA MEMBRANE LUNG FOR LONG TERM VENTILATOR REPLACEMENT DTZ NOVALUNG GMBH UNK 8003272006

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention IMMUNOTHERAPY| LONG-TERM ANTIBIOTICS| CARDIAC DRUGS