BEUDAMED
    FDA Adverse Event Death Summary report: N

    RENASYS GO RENTAL DEVICE

    MDR report key: 3168460 · Received June 13, 2013

    Report

    Report Number
    3006760724-2013-00006
    Event Type
    Death
    Date Received
    June 13, 2013
    Report Date
    June 12, 2013
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOTIFICATION OF THIS EVENT WAS RECEIVED VIA THE LOCAL TISSUE VIABILITY NURSE. DUE TO CIRCUMSTANCES SURROUNDING THIS EVENT, BOTH THE DEVICE AND PATIENT NOTES HAVE BEEN REMOVED FROM THE HOSPITAL. THEREFORE, IT IS DIFFICULT TO OBTAIN CLEAR AND CONCISE INFORMATION, NOR HAS THE DEVICE BEEN RETURNED OR MADE AVAILABLE TO SMITH & NEPHEW FOR EVALUATION. AN INVESTIGATION IS ONGOING, AND RESULTS OF OUR INVESTIGATION, INCLUDING DEVICE EVALUATION (IF RECEIVED FOR ASSESSMENT) WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    RENASYS GO WAS APPLIED SEVEN (7) DAYS POST SURGERY. THERAPY WAS APPLIED ON SUNDAY, (B)(6) AND THE PATIENT WAS DISCHARGED HOME ON (B)(6) WITH THE UNIT IN SITU. THE PUMP WAS ALLEGEDLY ALARMING CANISTER FULL - THE CANISTER WAS FOUND FULL OF BLOOD, AND WAS LEAKING FROM THE WOUND SITE. PATIENT DIED AT HOME ON (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268272 RENASYS GO RENTAL DEVICE PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164

    Patients

    Seq Age Sex Outcome Treatment
    1 Death