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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KCI USA, INC. V.A.C. GRANUFOAM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP

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KCI USA, INC. V.A.C. GRANUFOAM; NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Erythema (1840); Foreign Body In Patient (2687); No Code Available (3191)
Event Date 09/28/2019
Event Type  malfunction  
Event Description
Patient had pinhole-sized right groin wound with high volume of serous/lymph drainage, and incisional wound vac was placed (i.E., vac dressing placed on surface of skin, not packed inside).Patient was discharged home next day, with a home care nursing agency following the wound vac and orders to change dressing 3x/week.Two weeks later, patient presented to hospital's ed with right groin edema and erythema to now closed wound area.A surgeon was consulted, opened and cleaned the wound, packed it with two pieces of black foam, and replaced wound vac (now inside rather than surface/incisional).The surgeon did not fill out a dressing label with number/type of sponge.After three more weeks, patient admitted to outside hospital for unrelated condition.During that admission, a wound care specialty nurse was consulted, and a lower extremity ultrasound was negative for fluid collection or abscess.The wound vac was disconnected by wound care rn and the appropriate number of black foam pieces (based on most recent home care nursing documentation) were removed with site exploration negative for additional pieces.Patient discharged two days later with wet-to-dry dressing change instructions from wound care.Patient presented at office visit with surgeon with complaints of continual drainage, edema, and erythema at right groin site.The next day, patient underwent a right groin exploration surgery which revealed a retained foreign body resembling a black vac sponge.The sponge appeared to be covered in granulation tissue.Patient was discharged home and a follow-up office visit approx.One week later, indicated that the wound was healing well with no further issues.Later investigation of home care nursing agency's documentation revealed that rn only documented removal of one piece of black foam during first dressing change after patient's discharge from ed.After removal of top piece of foam, site began bleeding profusely and rn placed pressure dressing.Patient then went to outside hospital ed when bleeding did not cease, and ed attending physician documented a "blood clot" in the base of the wound.We suspect that this blood clot was actually the black foam sponge soaked in blood.An alternate possibility is that a piece of sponge was retained during one of the numerous dressing changes the patient received at home for approx.3 weeks between when the vac was placed inside the wound and when it was discontinued by wound care at the outside hospital.It could have also been retained when the vac was removed, but this seems less likely given the granulation tissue over the sponge (< 1 week between discontinuation of vac and wound exploration surgery) and the fact that an experienced wound care nurse discontinued it.We recommend that the manufacturer considers: (1) adding a radiopaque strip/grid to the sponges (to detect a retained sponge sooner); and (2) changing the color of the sponges (e.G., something neon or similar, so as not to blend into wound bed/flesh so easily).Additionally, we recommend exploring some kind of forcing function on the pump itself to remind providers to fill-out the dressing label.
 
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Brand Name
V.A.C. GRANUFOAM
Type of Device
NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP
Manufacturer (Section D)
KCI USA, INC.
12930 ih 10 west
san antonio TX 78249
MDR Report Key10447604
MDR Text Key204192736
Report Number10447604
Device Sequence Number1
Product Code OMP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/21/2020
Event Location Home
Date Report to Manufacturer08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age23725 DA
Patient Weight68
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