BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLUER-EVAC SAHARA DRAINAGE SYSTEM

    MDR report key: 1702073 · Received May 27, 2010

    Report

    Report Number
    3004365956-2010-00061
    Event Type
    Death
    Date Received
    May 27, 2010
    Date of Event
    April 11, 2010
    Report Date
    April 30, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KDQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE IS AVAILABLE FOR INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THE EVENT AS: AFTER URGENT DRAINAGE OF BILATERAL PNEUMOTHORAXES, THE PT HAD A CT SCAN. IT WAS FOUND THAT THE DRAINS WERE IN THE PROPER POSITION, BUT THE TENSION PNEUMOTHORAXES PERSISTED. THE DEVICE WAS CHANGED OUT AND THE CONDITION PERSISTED. AFTER CHANGING DEVICE TO A COMPETITIVE SYSTEM, PNEUMOTHORAXES DISAPPEARED. THE PT DIED DURING AN URGENT THORACOTOMY DUE TO MULTIPLE SEVERE INJURIES. ADDITIONAL INFO OBTAINED STATED, THE PT DIED DUE TO POLYTRAUMA AND TOTAL ORGAN FAILURE. CARDIOPULMONARY RESUSCITATION WAS PERFORMED WITHOUT SUCCESS. THE REPORT STATES THE DEATH OF THE PT HAD NO DIRECT CONNECTION WITH THE USE OF MALFUNCTIONING DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUER-EVAC SAHARA DRAINAGE SYSTEM PLUER-EVAC CHEST DRAINAGE SYSTEM KDQ TELEFLEX MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death