BEUDAMED
    FDA Adverse Event Other Summary report: N

    V.A.C. THERAPY SYSTEM

    MDR report key: 752129 · Received August 16, 2006

    Report

    Report Number
    1625774-2006-00041
    Event Type
    Other
    Date Received
    August 16, 2006
    Report Date
    July 17, 2006
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    k032310
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY THE HEALTH CARE PROVIDER (CASE MANAGER OF THE HOME HEALTH AGAENCY) INDICATES THAT THE PATIENT HAD A RIGHT GROIN WOUND FOLLOWING VASCULAR BYPASS GRAFT SURGERY. SHE FURTHER INDICATES THAT THE PATIENT HAD A VASCULAR GRAFT INFECTION. THE HEALTH CARE PROVIDER ALSO INDICATES THAT THE PATIENT WAS ON ANTICOAGULANTS AND HAD SOME BLEEDING PREVIOUSLY, BUT THEY WERE ABLE TO CONTROL IT. THIS SECOND EPISODE OF BLEEDING OCCURRED AND THEY COULDN'T GET IT TO STOP BLEEDING. SHE INDICATES THAT THE BLEEDING WAS DISCOVERED DURING THE DRESSING CHANGE, SO THEY PUT GAUZE IN THE WOUND AND TOOK THE PATIENT TO THE DOCTOR AND THE DOCTOR DISCONTINUED V.A.C. THERAPY. THE HEALTH CARE PROVIDER FURTHER INDICATES THAT THE PATIENT HAS ANOTHER TYPE OF DRESSING IN THE WOUND. V.A.C. LABELING STATES: "PRECAUTIONS SHOULD BE TAKEN FOR PATIENTS WITH ACTIVE BLEEDING, DIFFICULT WOND HEMOSTASIS, AND ANTICOAGULANTS". IT FURTHER STATES: "WHEN PLACING THE V.A.C. DRESSING IN CLOSE PROXIMITY TO BLOOD VESSELS OR ORGANS, TAKE CARE TO ENSURE THAT ALL VESSLES ARE ADEQUATELY PROTECTED WITH OVERLYING FASCIA, TISSUE OR OTHER PROTECTIVE BARRIERS. GREATER CARE SHOULD BE TAKEN WITH RESPECT TO WEAKENED, IRRADIATED OR SUTURED BLOOD VESSELS OR ORGANS". THERE WAS NO INDICATION OR REPORT OF A DEVICE MALFUNCTION, AND THE CASE MANAGER FELT THAT THE INCIDENT OCCURRED BECAUSE OF THE ANTICOAGULANTS. THE DEVICE WAS FOUND TO BE OPERATING PROPERLY AND WITHIN SPECIFICATIONS WHEN TESTED UPON RETURN TO THE KCI SERVICE CENTER. KCI IS REPORTING THIS INCIDENT BECAUSE THE DEVICE WAS IN USE PRIOR TO MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECEIVING V.A.C. THERAPY ON A RIGHT GROIN WOUND FOLLOWING VASCULAR BYPASS GRAFT SURGERY DEVELOPED BLEEDING AT THE WOUND SITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention