BEUDAMED
    FDA Adverse Event Death Summary report: N

    PERFUSION KITS & PACKS

    MDR report key: 139015 · Received December 18, 1997

    Report

    Report Number
    1222008-1997-00198
    Event Type
    Death
    Date Received
    December 18, 1997
    Date of Event
    September 10, 1997
    Report Date
    September 11, 1997
    Manufacturer
    TEXAS MEDICAL PRODUC
    Product Code
    DWF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WHICH WAS CLEARLY LABELED UNSTERILE, WAS USED WITH THE PT FOR THE DURATION OF THE CASE. THE PT REC'D ANTIBIOTICS PER STANDARD HOSP PROTOCOL. THE PT CODED ON THE FLOOR SMOETIME LATER, RETURNED TO ICU, THEN BACK TO OR FOR ADD SURG. PT FOUND TO HAVE SEVERE STERNUM INFECTION. RETURNED TO SURG, THEN ICU, EXPIRED 9 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERFUSION KITS & PACKS PERFUSION PACK DWF TEXAS MEDICAL PRODUC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death