BEUDAMED
    FDA Adverse Event Death Summary report: N

    2.0 FR V-CATH

    MDR report key: 569116 · Received January 28, 2005

    Report

    Report Number
    569116
    Event Type
    Death
    Date Received
    January 28, 2005
    Date of Event
    January 14, 2005
    Report Date
    January 24, 2005
    Manufacturer
    HDC CORPORATION
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT ANORECTOPLASTY IN 2005. PT HAD A PICC LINE PLACED THE PREVIOUS DAY FOR ADMINISTRATION OF IV FLUIDS AND ANTIBIOTICS. PT WAS DOING WELL POST-OPERATIVELY UNTIL THE EARLY MORNING HOURS FIVE DAYS LATER. PT HAD INCREASED IRRITABILITY AND AT APPROXIMATELY 7:30 A.M. WAS GIVEN MORPHINE. PT BECAME BRADYCARDIC AND THEN CODED. THE CODE WAS UNSUCCESSFUL AND PT EXPIRED. THE AUTOPSY REVEALED THAT A PIECE OF THE PICC CATHETER WAS BROKEN AND LYING IN THE ATRIUM. THERE WAS ALSO WHAT LOOKED TO BE IV FLUIDS SURROUNDING THE HEART. AT THIS POINT THE CAUSE OF DEATH IS BELIEVED TO BE IV FLUIDS IN THE PERICARDIUM CAUSING A TAMPONADE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.0 FR V-CATH PICC DQO HDC CORPORATION * 1005

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DAY Death 3. LIPIDS - 2005.| 2. PIPERCILLIN - 2005,| 1. TPH - 2005,