BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEO V-CATH 2.0 FR

    MDR report key: 560956 · Received December 21, 2004

    Report

    Report Number
    MW1034004
    Event Type
    Death
    Date Received
    December 21, 2004
    Date of Event
    May 9, 2004
    Report Date
    December 21, 2004
    Manufacturer
    HDC CORP.
    Product Code
    DQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    PT WAS NOT ON A VENTILATOR. PT HAD AN EXCELLENT PROGNOSIS. FAMILY MEMBER WAS APPROACHED BY THE NEONATOLOGIST AT HOSPITAL. PT RECOMMENDED FAMILY MEMBER CONSENT TO PLACEMENT OF A PICC LINE. IT WAS PLACED IN THE RIGHT ATRIUM. THREE DAYS LATER PT WENT INTO CARDIAC ARREST AND WOULDN'T RESPOND TO LIFE SAVING MEASURES. THE AUTOPSY CONCLUDED PT DIED OF CARDIAC TAMPONADE, MYOCARDIAL PERFORATION, AND PERICARDIAL EFFUSION. THERE WERE 25 CC'S OF TPN FLUID THAT BUILT UP (PT WAS GETTING 7 CC'S PER HOUR). PT HAD NO OTHER HEALTH PROBLEMS WHATSOEVER. THE LINE HAD ACCORDING TO MED RES MIGRATED SEVERAL TIMES AND HAD TO BE RETRACTED PRIOR TO DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEO V-CATH 2.0 FR PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) DQO HDC CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DAY Death