BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2000815 · Received February 17, 2011

    Report

    Report Number
    1625774-2011-00019
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 1, 2008
    Report Date
    January 20, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABELING, AVAILABLE IN PRINT AND ONLINE, STATES NEVER LEAVE A V.A.C. DRESSING IN PLACE WITHOUT ACTIVE V.A.C. THERAPY FOR MORE THAN 2 HRS. IF THERAPY IS OFF FOR MORE THAN 2 HRS, 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 ALTERNATE DRESSING AT THE DIRECTION OF THE TREATING CLINICIAN. THE V.A.C. THERAPY SYSTEM INCLUDE ALARMS THAT SIGNAL TUBING BLOCKAGES, A FULL OR MISSING CANISTER, INACTIVE THERAPY, LOW BATTERY, LEAKS IN THE SEAL OF THE DRESSING, AND A LOW PRESSURE ALARM IN THE ACTIV.A.C. AND INFOV.A.C. MODELS. THE BATTERY CRITICAL IS DESIGNED TO SOUND WITH 30 MINS OF BATTERY POWER REMAINING. DEVICE LABELING INDICATES TO IMMEDIATELY RECHARGE BATTERY. ENSURE POWER CORD IS SECURELY CONNECTED TO THERAPY UNIT. CHARGE V.A.C. THERAPY UNIT AT LEAST TWICE A DAY... MONITOR CONTINUOUSLY AND CHECK AND RESPOND TO ALARMS.

    Description of Event or Problem · 1

    ON (B)(4) 2011, THE FOLLOWING INFO WAS OBTAINED FROM A LITERATURE REVIEW OF A RETROSPECTIVE STUDY PUBLISHED AS AN ARTICLE IN A LOCAL NEWSPAPER: THE PT HAD A PROXIMAL TIBIA FRACTURE SURGICAL WOUND DEHISCENCE. IT WAS ALLEGED THAT THE UNIT WAS UNPLUGGED FROM ITS PRIMARY SOURCE AND THE BATTERY APPEARED TO HAVE BEEN DEPLETED OF ADEQUATE POWER TO MAINTAIN THERAPY. V.A.C. THERAPY WAS INTERRUPTED FOR AN UNK AMOUNT OF TIME. IT WAS ALSO ALLEGED THAT THE V.A.C. AUDIBLE ALARMS WERE TOO LOW FOR A HOSPITAL SETTING. ONCE THE INCIDENT WAS DETECTED THE ARTICLE CLAIMS THAT WOUND HAD AN INCREASE OF DRAINAGE AND VIABLE TISSUE. ON AN UNK DATE, THE PT UNDERWENT SURGERY WITH AN INCISION AND DRAINAGE OF THE WOUND. THE WOUND V.A.C. DRESSING WAS CHANGED. NO FURTHER INFO IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention