BEUDAMED
    FDA Adverse Event Death Summary report: N

    E-Z CARE NPWT PUMP (RENTAL UNIT)

    MDR report key: 1437906 · Received August 11, 2009

    Report

    Report Number
    1017593-2009-00006
    Event Type
    Death
    Date Received
    August 11, 2009
    Date of Event
    March 23, 2009
    Report Date
    August 11, 2009
    Manufacturer
    SMITH & NEPHEW INC., WOUND MANAGEMENT
    Product Code
    BTA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL REQUESTS MADE FOR ADDITIONAL INFORMATION FROM INITIAL REPORTER (MEDICAL CENTER). LOT/SERIAL NUMBER OF THE PUMP WAS NOT PROVIDED, PART NUMBER/LOT NUMBER OF THE ASSOCIATED DRESSING KIT WAS ALSO NOT PROVIDED. DATE OF PATIENT DEATH NOT PROVIDED IN INITIAL REPORT OR IN FOLLOW-UP REQUESTS. IN THE ABSENCE OF NECESSARY PRODUCT DETAILS SUCH AS SPECIFIC PART NUMBERS AND LOT/SERIAL NUMBERS WE ARE UNABLE TO PERFORM A DETAILED MANUFACTURER INVESTIGATION/ASSESSMENT AT THIS TIME. SHOULD ADDITIONAL, NECESSARY INFORMATION BE MADE AVAILABLE, AN INVESTIGATION SUMMARY WILL BE FILED IN A SUPPLEMENT REPORT.

    Description of Event or Problem · 1

    PATIENT DEATH OCCURRED DURING NPWT. THE PATIENT HAD MULTIPLE CO-MOBIDITIES, AND THE CHARGE NURSE WAS PRESENT IN THE ROOM. THE PATIENT'S FAMILY DID NOT WANT THEM TO REPAIR/CHANGE THE DRESSING WHICH WAS LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 E-Z CARE NPWT PUMP (RENTAL UNIT) BTA (DRESSING, WOUND, DRUG) BTA SMITH & NEPHEW INC., WOUND MANAGEMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Death NPWT WOUND DRESSING KIT USED IN CONJUNCTION WITH| NPWT PUMP| PROVIDED| PART NUMBER / LOT NUMBER OF DRESSING KIT NOT