BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 1061689 · Received June 13, 2008

    Report

    Report Number
    1625774-2008-00023
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 14, 2008
    Report Date
    May 14, 2008
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE MANAGER AT THE HOSPITAL INDICATED THAT V.A.C. DID NOT MALFUNCTION BUT BOTH THE HOSPITAL THAT DISCHARGED PT, AND THE HOME HEALTH AGENCY FAILED TO FOLLOW INSTRUCTIONS FOR USE. ACCORDING TO THE NURSE MANAGER, UPON CONTINUATION OF V.A.C. THERAPY, THE HOME HEALTH AGENCY WAS GIVEN CLEAR INSTRUCTIONS. V.A.C. LABELING STATES IN THE "INTRODUCTION" UNDER "POINTS TO REMEMBER WHEN USING V.A.C. WOUND THERAPY", KEEP V.A.C. THERAPY ON FOR AT LEAST 22 HOURS IN A 24 HOUR PERIOD. DO NOT LEAVE THE V.A.C. DRESSING IN PLACE IF THERAPY UNIT IS SWITCHED OFF FOR MORE THAN 2 HOURS IN 24." IT ALSO STATES UNDER "WARNINGS", "KEEP V.A.C. THERAPY ON: NEVER LEAVE A V.A.C. DRESSING IN PLACE WITHOUT ACTIVE V.A.C. THERAPY FOR MORE THAN 2 HOURS. IF THERAPY IS OFF FOR MORE THAN 2 HOURS, REMOVE THE OLD DRESSING AND IRRIGATE THE WOUND. EITHER APPLY A NEW V.A.C. DRESSING FROM AN UNOPENED STERILE PACKAGE AND RESTART V.A.C. THERAPY; OR APPLY AN ALTERNATIVE DRESSING AT THE DIRECTION OF THE TREATING CLINICIAN."

    Description of Event or Problem · 1

    IN 2008, THE PT WAS SENT HOME WITH A V.A.C. DRESSING IN PLACE ON HIS COCCYX BUT WITH NO V.A.C UNIT. IT IS REPORTED THAT THE FACILITY KNEW THE PT HAD A V.A.C. UNIT AT HOME THAT WAS NOT FUNCTIONAL AND DISCHARGED HIM ANYWAY. ON THE NEXT DAY, A NURSE WENT TO THE PTS HOUSE TO APPLY THE UNIT BUT IT WAS NOT WORKING, SO THE NURSE LEFT WITHOUT REMOVING THE DRESSING. ON THE FOLLOWING DAY, THE PT WENT TO THE PHYSICIAN'S OFFICE AND THE NURSE MGR WAS ABLE TO REMOVE THE DRESSING IN ONE PIECE AFTER SOAKING WITH NORMAL SALINE SOLUTION. THE NURSE MANAGER REPORTED THE WOUND WAS FOUL SMELLING AND THERE WAS MUCH DRAINAGE PRESENT. THE PT WAS PLACED ON ORAL ANTIBIOTICS AND WET TO MOIST DRESSINGS. ON A WEEK LATER WHEN THE PT RETURNED TO THE PHYSICIAN'S OFFICE FOR FOLLOW UP, THE NURSE MANAGER REPORTED HE WAS WEAK, DEHYDRATED AND HAD DIARRHEA SO HE WAS ADMITTED TO THE HOSPITAL. ACCORDING TO THE NURSE MANAGER, DURING HOSPITALIZATION, A COLOSTOMY WAS PERFORMED TO DIVERT STOOL, SO THE WOUND COULD HEAL. ON SIX DAYS LATER FOLLOW UP WITH DOCTOR, PT WAS PLACED BACK ON V.A.C. THERAPY WITH CLEAR INSTRUCTIONS PROVIDED TO THE HOME HEALTH AGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V.A.C. THERAPY SYSTEM JCX KCI USA, INC. FREEDOM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention