BEUDAMED
    FDA Adverse Event Death Summary report: N

    V.A.C.

    MDR report key: 837230 · Received April 6, 2007

    Report

    Report Number
    1625774-2007-00010
    Event Type
    Death
    Date Received
    April 6, 2007
    Date of Event
    March 1, 2007
    Report Date
    March 7, 2007
    Manufacturer
    KCI USA, INC.
    Product Code
    JCX
    PMA / PMN Number
    k062227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RISK MANAGER OF THE FACILITY INDICATES THE PATIENT WAS DISCHARGED HOME IN 2007 FOLLOWING AN OPEN STERNOTOMY FOR A TRIPLE CORONARY ARTERY BYPASS GRAFT. TWO DAYS LATER, THE PATIENT WAS READMITTED TO THE HOSPITAL WITH TACHYCARDIA, FEVER AND HEART PALPITATIONS. THE FOLLOWING DAY, THE PATIENT DEVELOPED SHORTNESS OF BREATH AND THE FEVER CONTINUED. TWO INCHES OF THE LOWER PART OF THE STERNAL WOUND WAS OPENED AND A LARGE AMOUNT OF PURULENT DRAINAGE WAS IRRIGATED OUT. THREE DAYS LATER, ANOTHER THREE INCHES OF THE WOUND OPENED AND V.A.C. THERAPY WAS INITIATED. THE FOLLOWING MONTH AT 3:00 PM, THE PHYSICIAN AND NURSE PERFORMED THE THIRD DRESSING CHANGE. SHORTLY AFTER THE PHYSICIAN AND NURSE LEFT THE ROOM, ANOTHER NURSE FOUND THE PATIENT AND HAD TO INITIATE A "CODE BLUE." THE PHYSICIAN NOTES INDICATE THAT THERE WAS FLUID RESUSCITATION, DOPAMINE INITIATED AND THE PATIENT WAS INTUBATED. THE PATIENT WAS PRONOUNCED DEAD AT 3:15 PM. BASED ON THE PHYSICIAN'S DISCHARGE SUMMARY (RIGHT VENTRICULAR RUPTURE SECONDARY TO CORONARY BYPASS GRAFT AND STERNAL ABSCESS), IT DOES NOT APPEAR THAT THE V.A.C. DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. KCI IS REPORTING THIS EVENT PURSUANT TO THE CURRENT MDR POLICY. THE PATIENT WAS ON NUMEROUS MEDICATIONS INCLUDING TWO DOES OF HEPARIN RECEIVED ON ADMISSION (2007) AND ONE DOSE OF COUMADIN RECEIVED FOUR DAYS LATER. THE PATIENT HAD A WOUND INFECTION OF WHICH METHICILLIN-SUSCEPTIBLE STAPHYLOCOCCUS AUREUS WAS CULTURED. THE PATIENT WAS RECEIVING SEVERAL ANTIBIOTICS WHICH INCLUDED MAXIPIME, VANCOMYCIN AND OXICILLIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF DIABETES, HYPERTENSION, OBSTRUCTIVE SLEEP APNEA AND CORONARY ARTERY DISEASE UNDERWENT AN OPEN STERNOTOMY FOR A TRIPLE CORONARY ARTERY BYPASS GRAFT (THIS WAS A REDO FOR A CORONARY ARTERY BYPASS GRAFT THAT WAS DONE IN 1990). THE PATIENT WAS PLACED ON V.A.C. THERAPY AFTER RE-ADMISSION TO THE HOSPITAL FOR A STERNAL WOUND ABSCESS. THE PATIENT DEVELOPED BLEEDING SHORTLY AFTER THE THIRD DRESSING CHANGE AND SUBSEQUENTLY DIED. THE MEDICAL RECORD INDICATES THAT THERE WAS A HOLE IN THE RIGHT VENTRICLE. THERE WAS NO AUTOPSY DONE BECAUSE THE PATIENT'S SPOUSE REFUSED. THE PHYSICIAN'S DISCHARGE SUMMARY INDICATES THE CAUSE OF DEATH AS RIGHT VENTRICULAR RUPTURE SECONDARY TO CORONARY ARTERY BYPASS GRAFT AND STERNAL ABSCESS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death