BEUDAMED
    FDA Adverse Event Injury Summary report: N

    V.A.C. ATS

    MDR report key: 3875005 · Received June 2, 2014

    Report

    Report Number
    3009897021-2014-00058
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    KCI USA, INC.
    Product Code
    OMP
    PMA / PMN Number
    K062227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, IT CANNOT BE DETERMINED THAT THE ALLEGED DEBRIDEMENTS OR WOUND DEHISCENCE IS RELATED TO V.A.C. THERAPY. KCI HAS NOT BEEN ABLE TO OBTAIN SUFFICIENT INFO TO ESTABLISH A ROOT CAUSE.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO KCI BY THE KCI (B)(4) REP: THE PHYSICIAN REPORTED ON (B)(6) 2014, THE PT EXPERIENCED SIGMOID COLON ENTERITIS NECROTICANS AND THE HARTMAN'S PROCEDURE WAS PERFORMED. THE PT THEN EXPERIENCED ABDOMINAL COMPARTMENT SYNDROME AND THE PT'S ABDOMEN WAS OPENED TO PREVENT INCREASED ABDOMINAL PRESSURE. THE INTESTINES WERE COVERED WITH AN ISOLATION BAG WITH OPEN HOLES TO PREVENT DRYNESS, AND A WET TOWEL WAS PLACED ON TOP OF THE ISOLATION BAG. THEN, A PLASTIC BAG WAS APPLIED FOR NEGATIVE PRESSURE WOUND THERAPY. ON (B)(6) 2014, A SURGICAL DEBRIDEMENT WAS PERFORMED. THE INTESTINES WERE COVERED WITH AN ISOLATION BAG. SLICED GRANUFOAM DRESSING WAS APPLIED ON TOP OF THE ISOLATION BAG AND WAS SUTURED AT THE ABDOMINAL WALL EDGE. DUE TO SEVERE EDEMA, THE ENTIRE ABDOMEN WAS NOT ABLE TO BE COMPLETELY COVERED WITH FOAM BUT WAS COVERED WITH DRAPES. EIGHT DRAINS WERE INSERTED INTO BOTH SIDES OF THE ABDOMEN, AND V.A.C. THERAPY WAS APPLIED. THREE DRAINS REMAINED. ON (B)(6) 2014, A TOTAL OF 2 LITERS OF DRAINAGE WAS REMOVED WITH NO PROBLEMS NOTES. ON (B)(6) 2014, UPON PERFORMING A DRESSING CHANGE, DECREASED EDEMA WAS NOTED. "WHILE LOOSENING INTESTINES, AN IRRIGATION AN ABDOMINAL WALL DEBRIDEMENT WAS PERFORMED, AND V.A.C. THERAPY WAS APPLIED. ON (B)(6) 2014, AN ABDOMINAL WOUND DEBRIDEMENT WAS PERFORMED AND IT WAS NOTED THAT THE CONDITION OF EDEMA HAD NOT SIGNIFICANTLY CHANGED FROM (B)(6) 2014. ON (B)(6) 2014, THE DRAINAGE ALLEGEDLY BECAME A BROWN MUDDY COLOR. THE PT WAS SCHEDULED FOR AN OPERATION THE SAME DAY, AND THE FOAM WAS REMOVED IN SURGERY. THE RECTAL SIDE OF INTESTINE WAS CLOSED WITH STAPLES AND SUTURES. ALTHOUGH THE STAPLES REMAINED IN PLACE, A PARTIAL AREA OF THE SUTURED SITE OPENED, AND STAPLES WERE RE-APPLIED. THE OPENED ANASTOMOSIS SITE AND INTESTINAL NECROSIS WERE NOT OBSERVED, AND A DEBRIDEMENT WAS NOT PERFORMED. THE ABDOMEN WAS ALLEGEDLY CONTAMINATED WITH DRAINAGE AND NORMAL SALINE IRRIGATION WAS PERFORMED. A PLANNED BILATERAL THIGH FLAP WAS PERFORMED. ON (B)(6) 2014, THE PT'S CONDITION WAS STABLE WITH NO TROUBLE." ON (B)(6) 2014, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI (B)(4) FIELD SERVICE, AND THE UNIT PASSED THE QC CHECKS AND MET SPECIFICATIONS. ON (B)(6) 2014, THE DEVICE WAS TESTED PER QUALITY CONTROL (QC) PROCEDURE BY KCI (B)(4) FIELD SERVICE, AND THE UNIT PASSED THE QC CHECK AND MET SPECIFICATIONS. NO REPAIRS WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322571 V.A.C. ATS OMP KCI USA, INC. WNDATS 50760615

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention