BEUDAMED
    FDA Adverse Event Death Summary report: N

    L - CATH PEEL AWAY SYSTEM PLACEMENT SET

    MDR report key: 618549 · Received June 29, 2005

    Report

    Report Number
    618549
    Event Type
    Death
    Date Received
    June 29, 2005
    Date of Event
    May 23, 2005
    Report Date
    June 29, 2005
    Manufacturer
    BD
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A PATIENT HAD A PICC PLACED FOR IV INFUSIONS. A CHEST X-RAY WAS OBTAINED POST PICC PLACEMENT PRIOR TO INITIATING IV INFUSIONS BUT WAS ERRONEOUSLY INTERPRETED AS BEING IN THE SUPERIOR VENA CAVA BY THE ATTENDING PHYSICIAN. THE RADIOLOGIST CORRECTLY INTERPRETED THE PLACEMENT AS BEING IN THE RIGHT VENTRICLE HOWEVER THE RADIOLOGIST FORGOT TO CALL THE ATTENDING PHYSICIAN AS PER PROTOCOL. THE RADIOLOGIST HAD NO IDEA THAT A PICC LINE COULD ERODE THROUGH MAJOR ORGANS. IF THE RADIOLOGIST HAD KNOWN, AWARENESS TO CALL THE ATTENDING PHYSICIAN MIGHT HAVE BEEN HEIGHTENED. FOUR DAYS POST PICC PLACEMENT, THE PATIENT BEGAN DETERIORATING AND ENDED UP BEING CODED. THE PATIENT DID NOT SURVIVE THE RESUSCITATION ATTEMPT. INITIALLY THE PATIENT WAS THOUGHT TO HAVE DEVELOPED SEPSIS HOWEVER AN AUTOPSY REPORT REVEALED DEATH WAS DUE TO PERICARDIAL TAMPONADE SECONDARY TO PERFORATION OF THE RIGHT VENTRICLE FOLLOWING PLACEMENT OF THE PICC. AGE WAS A SIGNIFICANT CONTRIBUTING CONDITION ALSO NOTED IN THE AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L - CATH PEEL AWAY SYSTEM PLACEMENT SET PICC DQO BD * LMP 5266

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death