BEUDAMED
    FDA Adverse Event Death Summary report: N

    V.A.C. THERAPY

    MDR report key: 3659129 · Received February 18, 2014

    Report

    Report Number
    3009897021-2014-00008
    Event Type
    Death
    Date Received
    February 18, 2014
    Date of Event
    January 15, 2014
    Report Date
    January 17, 2014
    Manufacturer
    KCI USA INC.
    Product Code
    OMP
    PMA / PMN Number
    K063692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION FROM THE PT'S DEATH CERTIFICATE THAT SUGGESTS VAC THERAPY CAUSED OR CONTRIBUTED TO THE VASCULAR HEMORRHAGE AND TO THE PT EXPIRING. KCI HAS MADE SEVERAL ATTEMPTS TO GATHER ADDITIONAL INFO, BUT THERE HAS BEEN NO RESPONSE.

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS REPORTED TO KCI BY THE NURSE: ON (B)(6) 2014, THE NURSE ALLEGED THE PT "BLED OUT" AND DIED ON THE WAY TO THE HOSPITAL. AS PER THE NURSE: ON (B)(6) 2013, THE PT HAD A FEMORAL POPLITEAL BYPASS SURGERY TO THE LEFT MEDIAL KNEE. ON (B)(6) 2013, THE PT TORE OPEN HIS SUTURES. NO ADD'L INFO WAS PROVIDED FOR RESOLUTION OF THE OPEN SUTURES. ON (B)(6) 2014, THE PT WAS PLACED ON VAC THERAPY. ON (B)(6) 2014, THE NURSE SPOKE TO THE PT'S WIFE WHO STATED THE PT HAD NORMAL SEROSANGUINOUS DRAINAGE ON (B)(6) 2014. ON (B)(6) 2014, THE WIFE ALLEGEDLY OBSERVED THE PT'S WOUND WAS BLEEDING AND REPORTED THE PT DIED IN TRANSIT TO THE HOSPITAL. THE WIFE STATED THE PT EXPERIENCED CHEST PAINS AND COLLAPSED. THE WIFE APPLIED PRESSURE ON THE BLEEDING WOUND AND CALLED 911. ON (B)(6) 2014, THE NURSE OBSERVED A CANISTER AND TUBING WERE FULL OF BLOOD. THE NURSE ALSO REPORTED CONFIRMING WITH THE PT'S WIFE, THAT THE PT HAD BEEN DRINKING SEVERAL ALCOHOLIC BEVERAGES A DAY. THE NURSE STATED SHE INFORMED THE PT TO AVOID ALCOHOL AS THE PT WAS TAKING NARCOTICS. THE NURSE CONFIRMED THE PT WAS ON PLAVIX AND THAT THE WIFE OBSERVED THE PT HAD BLOOD CLOTS UNDER THE DRESSING WHEN THE DRESSING WAS REMOVED. THE NURSE COULD NOT CONFIRM IF THE WIFE REMOVED THE DRESSING PRIOR TO APPLYING PRESSURE NOR COULD SHE CONFIRM OR DENY IF THE PT WAS ON VAC THERAPY AT THE TIME OF THE BLEEDING EVENT. AS PER PT'S DEATH CERTIFICATE: THE IMMEDIATE CAUSE OF DEATH WAS VASCULAR HEMORRHAGE. UNDERLYING CAUSES TO VASCULAR HEMORRHAGE INCLUDE SURGICAL COMPLICATIONS AS A CONSEQUENCE OF FEMORAL BYPASS. OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO DEATH INCLUDE CORONARY ARTERY DISEASE, CHRONIC OBSTRUCTION PULMONARY DISORDER, PERIPHERAL ARTERY DISEASE, HYPERTENSION AND TOBACCO USE. ON (B)(6) 2014, THE DEVICE PASSED QUALITY CONTROL CHECK AND MET SPECS. ON (B)(6) 2014, THE DEVICE WAS PLACED WITH THE PT. AS OF (B)(6) 2014, THE DEVICE HAD BEEN RETURNED TO KCI AND IS UNDERGOING EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101018 V.A.C. THERAPY OMP KCI USA INC. WNDACT

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death