MAUDE Adverse Event Report: KCI USA, INC. V.A.C.; NEGATIVE PRESSURE WOUND THERAPY SPONGE

Catalog Number M6275034/10

Device Problems Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978)

Patient Problems Abscess (1690); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Sepsis (2067)

Event Date 12/20/2013

Event Type  Injury  

Event Description

The patient was admitted from an out-of-state hospital (osh) for treatment of an abdominal abscess and infected mesh graft from prior abdominal surgeries for ventral hernia.The patient was taken to the operating room (or) for incision and drainage, pulse lavage and partial mesh removal.She was subsequently discharged with a plan for skilled home nursing care to manage the vacuum assisted closure (vac) dressings.She was readmitted to an osh 5 days later with sepsis and hypotension requiring intensive care unit (icu) care, intravenous (iv) fluid boluses, antibiotics and vasopressors.She was then transferred back to our hospital for a possible abscess noted on computed tomography (ct) scan at the osh.Upon arrival examination of the wound bed, we revealed a white retained vac sponge.The wound was cleaned and the patient was discharged 2 days later.We have instituted a vac sponge count policy at our institution to avoid this scenario, since a retained sponge can contribute to wound infection and poor patient outcomes.The white sponges absorb body fluid/blood and take on the appearance of the patient's regular tissue making them difficult to differentiate from tissue, especially if tissue starts to granulate over the sponges.Prior to this event we had asked the manufacturer to change the color of the sponges to something not associated with the human body.This would help with identification in large, tracking wounds, and hopefully lessen the risk of a retained object.In addition the dressings are non-radiopaque and do not show up on radiology images.Had they been radiopaque, it would have been seen on the ct scan performed at the outside hospital, possibly preventing the need to transfer this patient to a different out-of-state facility.

• Brand Name: V.A.C.
• Type of Device: NEGATIVE PRESSURE WOUND THERAPY SPONGE
• Manufacturer (Section D): KCI USA, INC.; 6203 farinon drive; san antonio TX 78249
• MDR Report Key: 3592476
• MDR Text Key: 4143993
• Report Number: 3592476
• Device Sequence Number: 1
• Product Code: LWH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: M6275034/10
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/16/2014
• Event Location: Other
• Date Report to Manufacturer: 01/27/2014
• Patient Sequence Number: 1
• Treatment: VACCUM ASSISTED WOUND THERAPY- V.A.C.
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 99