BEUDAMED
    FDA Adverse Event Death Summary report: N

    *

    MDR report key: 104132 · Received July 7, 1997

    Report

    Report Number
    104132
    Event Type
    Death
    Date Received
    July 7, 1997
    Date of Event
    April 7, 1997
    Report Date
    July 2, 1997
    Manufacturer
    VYGON CORP
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 3/22/97 A NEONATAL PERCUTANEOUS CENTRAL VENOUS CATHETER WAS INSERTED VIA THE (R) AXILLARY VEIN. ON 4/7/97 DURING AN INFUSION OF TPN AND A MEDICATION THROUGH THIS CATHETER, THE IV PUMP BEEPED DUE TO AN OCCLUSION. THE CATHETER WAS UNABLE TO BE FLUSHED DUE TO RESISTANCE UPON ATTEMPTED FLUSHING. A CHEST X-RAY WAS TAKEN TO CHECK PLACEMENT OF A NEW CENTRAL LINE INSERTED IN THE (L) ARM. THIS CHEST X-RAY AND A FOLLOW-UP ECHOCARDIOGRAM SHOWED THE END PORTION OF THE SUBJECT CATHETER PLACED ON 3/22/97 HAD DETACHED FROM THE REMAINDER OF THE CATHETER AND WAS FLOATING IN THE (R) ATRIUM. THE SUBJECT CATHETER WAS THEN REMOVED AND INSPECTION OF THIS CATHETER REVEALED THE CATHETER WAS MISSING 2.5 CM OF THE TIP. THE FINAL AUTOPSY REPORT/FINDINGS NOTED THE CATHETER TIP RETAINED IN THE HEART MAY HAVE CONTRIBUTED TO THE PT'S SEPSIS AND SEPSIS WAS THOUGHT TO HAVE CONTRIBUTED TO THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * NEONATAL PERCUTANEOUS CENTRAL VENOUS CATHETER DQO VYGON CORP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 DAY Death| L PLUM IV PUMP