BEUDAMED
    FDA Adverse Event Death Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2943985 · Received January 31, 2013

    Report

    Report Number
    3009897021-2012-00009
    Event Type
    Death
    Date Received
    January 31, 2013
    Date of Event
    August 11, 2012
    Report Date
    January 3, 2013
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE PATIENT'S MEDICAL RECORDS, THE PATIENT DEVELOPED A SACRAL ULCERATION DURING A HOSPITALIZATION AT (B)(6) HOSPITAL IN 2011. THE PATIENT WAS PLACED ON HOSPICE ON (B)(6) 2011. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM HOSPICE DUE TO EXHAUSTED HOSPICE MEDICAL COVERAGE. ALL OF THESE EVENTS OCCURRED PRIOR TO PLACEMENT OF V.A.C. THERAPY FOR ULCER TREATMENT. THERE IS NO INDICATION FROM THE PATIENT'S MEDICAL RECORDS THAT SUGGESTS V.A.C. THERAPY CAUSED OR CONTRIBUTED TO EITHER THE OSTEOMYELITIS OR THE PATIENT EXPIRING. IT CANNOT BE DETERMINED IF THE ALLEGED OSTEOMYELITIS IS RELATED TO V.A.C. THERAPY. KCI HAS MADE SEVERAL ATTEMPTS TO GATHER ADDITIONAL INFORMATION, BUT THERE HAS BEEN NO RESPONSE. ON (B)(4) 2012, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON (B)(4) 2012, THE DEVICE WAS DELIVERED TO THE PATIENT. THE DEVICE REMAINED WITH THE PATIENT UNTIL THE STOP BILL DATE WAS ENTERED ON (B)(4) 2012. THE DEVICE WAS RETURNED TO KCI FOR EVALUATION. INSPECTION AND TESTING OF THE DEVICE DID NOT REVEAL ANY EVIDENCE OF AN OPERATIONAL MALFUNCTION WITH THE UNIT.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT'S DAUGHTER ALLEGED THE PATIENT EXPIRED FROM A COLLAPSED LUNG A FEW DAYS AFTER THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO OSTEOMYELITIS, WHICH REQUIRED A SIGNIFICANT REGIME OF INTRAVENOUS ANTIBIOTIC THERAPY. V.A.C. THERAPY WAS DELIVERED TO THE PATIENT ON (B)(6) 2012. PER THE PATIENT'S MEDICAL RECORDS, ON (B)(6) 2012, THE PATIENT WAS PLACED ON V.A.C. THERAPY FOR A STAGE III SACRAL DECUBITUS PRESSURE ULCER WITH INCREASING DIMENSIONS. ON (B)(6) 2012, THE HOME CARE NURSE NOTED A FURTHER INCREASE IN THE WOUND DIMENSIONS AND NECROTIC AREAS, AS WELL AS AN ODOR, AND A MODERATE TO HEAVY AMOUNT OF BROWNISH-YELLOW DRAINAGE. THE PATIENT'S TEMPERATURE WAS DOCUMENTED TO BE 98.8 DEGREES TYMPANIC. V.A.C. THERAPY WAS REMOVED. THE PATIENT WAS REFERRED TO THE WOUND CARE CLINIC FOR WOUND MANAGEMENT. ON (B)(6) 2012, THE PATIENT WAS REFERRED TO ANOTHER PHYSICIAN FOR EVALUATION OF THE WOUND. THE DOCTOR NOTED EXPOSED BONE, UNDERMINING AND SLOUGH. NO SIGNS OF ACUTE CELLULITIS OR INFECTION WITH MINIMAL ODOR. A NON-EXCISIONAL DEBRIDEMENT WAS PERFORMED AND AN MRI WAS ORDERED TO RULE OUT OSTEOMYELITIS. ON AN UNKNOWN DATE, AN MRI SHOWED EVIDENCE OF OSTEOMYELITIS AND THE PATIENT WAS PLACED ON ORAL ANTIBIOTIC THERAPY. ON (B)(6) 2012, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER WOUND MANAGEMENT, AND THE PATIENT WAS PLACED ON INTRAVENOUS ANTIBIOTIC THERAPY. ON (B)(6) 2012, A RAPID RESPONSE ALERT WAS CALLED DUE TO AN ACUTE RESPIRATORY FAILURE, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. ON (B)(6) 2012, A CHEST X-RAY SHOWED "ALMOST COMPLETE COLLAPSE OF THE LEFT LUNG VERSUS COMBINATION OF ATELECTASIS/LEFT EFFUSION," AND THE PATIENT'S CHANCES OF SURVIVAL WERE NOTED AS "SLIM." THE SAME DAY, THE PATIENT WAS TRANSFERRED TO HOSPICE CARE WITH DISCHARGE DIAGNOSES OF ACUTE RESPIRATORY FAILURE DUE TO ASPIRATION PNEUMONIA, PROGRESSIVE MULTIPLE SCLEROSIS, AND SACRAL DECUBITUS ULCER WITH SACRAL OSTEOMYELITIS. ON (B)(6) 2012, THE PATIENT EXPIRED AT 1950.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42470 V.A.C. THERAPY SYSTEM OMP KCI USA INC. ACTIV.A.C.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death