BEUDAMED
    FDA Adverse Event Death Summary report: N

    VYGON

    MDR report key: 1676769 · Received May 4, 2010

    Report

    Report Number
    MW5015822
    Event Type
    Death
    Date Received
    May 4, 2010
    Date of Event
    April 26, 2010
    Report Date
    May 4, 2010
    Manufacturer
    VYGON CORPORATION
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B) (6) 2010, PICC LINE INSERTED. AT APPROX 0350, ON (B) (6) 2010, INFANT DEVELOPED SPONTANEOUS BRADYCARDIA WITH HEART RATE BETWEEN 70 AND 110. REQUIRED O2 AT 35% TO MAINTAIN ADEQUATE O2 SATURATIONS, BUT HEART RATE WOULD NOT IMPROVE; INFANT WAS INTERMITTENTLY HYPOXIC. A DOSE OF EPINEPHRINE ADMINISTERED HEART RATE INCREASED TO 140. INFANT DEVELOPED PROFOUND BRADYCARDIA, HEART RATE IN 30 - 50'S, AND THEN BECAME ASYSTOLIC. MD ABLE TO WITNESS ELECTRICAL ACTIVITY WITHOUT AUSCULTABLE CARDIAC SOUNDS. PERICARDIOCENTESIS PRODUCED APPROXIMATELY 1 ML OF MILKY FLUID, WHICH APPEARED TO BE CONSISTENT WITH TPN. ECHOCARDIOGRAM CONFIRMED THE EVIDENCE OF A PERICARDIAL EFFUSION AND UNDER ULTRASOUND GUIDANCE MD WAS ABLE TO REMOVE APPROX 7 ML OF WHAT APPEARED TO BE CHYLOUS FLUID. DESPITE RESUSCITATIVE EFFORTS, INFANT EXPIRED. MD SUSPECTS INFANT DEVELOPED A CARDIAC TAMPONADE SECONDARY TO A PERICARDIAL EFFUSION RESULTING FROM THE MIGRATION OF THE PICC CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VYGON PREMICATH (PICC) LJS VYGON CORPORATION 1261.20 037255

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DA Death