BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD EXT SET WITH T CONNECTOR

    MDR report key: 1193466 · Received October 7, 2008

    Report

    Report Number
    9613251-2008-00355
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K052722
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A HOLE IN THE TUBING SET; SUBSEQUENTLY BLOOD LOSS WAS NOTED. THE TUBING WAS BEING USED TO DELIVER UNSPECIFIED CONCENTRATIONS OF DOPAMINE, FENTANYL, TPN AND LIPIDS THROUGH AN UMBILICAL VENOUS CATHETER. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, IT WAS NOTED THAT BLOOD BACKED UP IN THE TUBING SET AND LEAKED FROM A HOLE AT THE Y-CONNECTOR OF THE TUBING SET. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THE CUSTOMER CONTACT REPORTED THAT THE PT'S BLOOD PRESSURE "FLUCTUATED" DURING THE TIME IT TOOK TO REPLACE THE IV TUBING SET; HOWEVER, NO MEDICAL INTERVENTIONS WERE REQUIRED. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD EXT SET WITH T CONNECTOR 80-FPA FPA HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DOPAMINE