BEUDAMED
    FDA Adverse Event Death Summary report: N

    V.A.C. ATS

    MDR report key: 4417322 · Received January 12, 2015

    Report

    Report Number
    3009897021-2015-00003
    Event Type
    Death
    Date Received
    January 12, 2015
    Report Date
    August 1, 2014
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    PMA / PMN Number
    K062227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNK WHEN THE EVENT OCCURRED AS THIS INFO HAS NOT BEEN PROVIDED. BASED ON INFO PROVIDED, IT CANNOT BE DETERMINED THAT THE INFECTION OR PT EXPIRING IS RELATED TO V.A.C. THERAPY.

    Description of Event or Problem · 1

    EP-2 "A CASE DEVELOPED PROBABLE TOXIC SHOCK SYNDROME UNDER V.A.C. THERAPY" INCLUDED IN THE 3RD ANNUAL MEETING OF (B)(6) SOCIETY FOR SURGICAL WOUND CARE REPORTED THAT A SUSPECTED TOXIC SHOCK SYNDROME WAS OBSERVED AFTER V.A.C. THERAPY, WHICH ALLEGEDLY ENDED IN THE DEATH OF THE PT. THE PT HAD A PARAPLEGIA CAUSED BY MYELITIS TRANSVERSE 30 YEARS AGO AND HAD UNDERWENT SEVERAL SURGERIES FOR SACRAL AND ISCHIAL PRESSURE ULCERS. "AROUND (B)(6) 2010, THE PT'S SACRAL PRESSURE ULCER WORSENED. IN (B)(6), THE PT UNDERWENT A SURGICAL DEBRIDEMENT FOR SKIN NECROSIS AND AN INFECTION. V.A.C. THERAPY WAS APPLIED WHEN THE SIGNS OF INFECTION HAD RESOLVED AND GRANULATION OCCURRED. TEN DAYS AFTER THE APPLICATION OF V.A.C. THERAPY, THE PT EXPERIENCED A FEVER, DECREASED URINE VOLUME, CPK AND HIGHER SERUM CREATININE LEVELS DESPITE A SUCCESSFUL GRANULATION PROCESS. THE PT UNDERWENT A POLYMYXIN IMMUNOADSORPTION AND WAS MOVED TO THE INTENSIVE CARE UNIT. ON THE 12TH DAY, THE PT EXPIRED DUE TO MULTIORGAN FAILURE. (B)(6) WAS OBSERVED BY WOUND INCUBATION, HOWEVER, BLOOD AND THROAT CULTURES WERE NEGATIVE. THE UNIT'S SERIAL NUMBER WAS NOT PROVIDED, THEREFORE, KCI CANNOT CONDUCT A DEVICE EVALUATION OF THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27599 V.A.C. ATS OMP KCI USA INC. WNDATS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death