BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 2324484 · Received October 31, 2011

    Report

    Report Number
    1625774-2011-00129
    Event Type
    Injury
    Date Received
    October 31, 2011
    Date of Event
    October 11, 2011
    Report Date
    October 11, 2011
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K062227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    WE ARE FILLING THIS REPORT DUE TO A POTENTIAL USE ERROR. ON 09/23/2011, THE DEVICE WAS TESTED PER QUALITY CONTROL PROCEDURE BY KCI FIELD SERVICE, AND THE UNIT PASSED THE QUALITY CONTROL CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2011, THE DEVICE WAS PLACED WITH THE PT. ON (B)(4) 2011, 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 OR FLUID INGRESS INSIDE THE UNIT. DEVICE LABELING STATES: ALWAYS FOLLOW STANDARD PRECAUTIONS: STANDARD PRECAUTIONS ARE PROVIDED FOR PERSONAL PROTECTION AND ARE DESIGNED TO REDUCE THE RISK OF TRANSMISSION OF MICROORGANISMS FROM BOTH KNOWN AND UNK SOURCES OF INFECTION. THESE PRECAUTIONS CAN BE APPLIED TO ALL PTS, REGARDLESS OF THEIR DIAGNOSIS OR PRESUMED INFECTION STATUS. STANDARD PRECAUTIONS SHOULD BE USED WHEN CONTACT IS ANTICIPATED WITH BLOOD AND ALL BODY FLUIDS. THIS ALSO INCLUDES SECRETIONS AND EXCRETIONS, EXCEPT SWEAT, REGARDLESS OF WHETHER BLOOD IS VISIBLE OR NOT, NON-INTACT SKIN (I.E., OPEN WOUNDS) AND MUCOUS MEMBRANES. MASK, EYE PROTECTION, FACE SHIELD. WEAR A MASK AND EYE PROTECTION OR A FACE SHIELD TO PROTECT THE MUCOUS MEMBRANES OF THE EYES, NOSE AND MOUTH DURING PROCEDURES, AND PT CARE ACTIVITIES THAT ARE LIKELY TO GENERATE SPLASHES OR SPRAYS OF BLOOD, BODY FLUIDS, SECRETIONS AND EXCRETIONS.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO KCI BY THE WOUND CARE NURSE: ON (B)(6) 2011, THE WOUND CARE NURSE WAS REMOVING THE CANISTER THAT WAS FULL OF EXUDATE AND REPLACING IT WITH A NEW CANISTER. BEFORE ATTACHING THE NEW CANISTER, THE WOUND CARE NURSE HAD THE V.A.C. FREEDOM NEXT TO HER FACE. AS SHE SNAPPED THE CANISTER IN PLACE, THE WOUND CARE NURSE FELT SOMETHING WET ON HER FACE AND EYE. THE NURSE WASHED HER FACE AND FLUSHED OUT HER EYE. AS A STANDARD PROTOCOL FOR THE HOSPITAL, THE NURSE IS GOING THROUGH A SERIES OF ANTIVIRAL TESTING AND PROPHYLACTIC MEDICATIONS SINCE THE PAT IS POSITIVE FOR A VIRAL INFECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other