MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. ACTIV.A.C.¿ THERAPY SYSTEM; OMP

Model Number WNDACC

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Bruise/Contusion (1754); Necrosis (1971); Necrosis Of Flap Tissue (1972)

Event Date 10/29/2018

Event Type  Death  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged dermal bruising, skin flap compromise, and necrosis are related to activ.A.C.¿ therapy.The physician clarified the patient did not experience a hematoma, and confirmed the dermal bruising, skin flap compromise, and necrosis were treated conservatively without surgical intervention.Device labeling, available in print and online, states: if a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance/expertise of a specialist: check the therapy hour meter to ensure that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day).If the number of therapy hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation.Clean wound more thoroughly during dressing changes.Evaluate for signs and symptoms of infection and, if present, treat accordingly.Change dressing often, ensuring that it is being changed at least every 48 hours.Examine the wound and debride as necessary.Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.Contraindications: v.A.C.® therapy is contraindicated for patients with necrotic tissue with eschar present.

Event Description

On (b)(6) 2018, the following information was reported to kci by the physician: the patient underwent a mastectomy, and a prevena¿ dressing with activ.A.C.¿ therapy system was applied.Later that evening, the patient alleged experiencing pressure and pain.The patient reportedly developed a hematoma.The activ.A.C.¿ therapy pressure setting was observed to be 200mmhg.The patient was switched to a prevena¿ incision management system.On (b)(6) 2018, the following information was reported to (b)(4) by the physician: the patient did not experience a hematoma.The patient allegedly developed extensive dermal bruising.The "pumps" were switched out once the alleged malfunction of the activ.A.C.¿ therapy was identified and the prevena¿ dressing stayed in place.The bruising matured, and the physician removed the prevena¿ dressing in order to assess the incision site.Upon prevena¿ dressing removal, the physician observed that the inferior skin flap was allegedly compromised.The end result was an area approximately 26.5mm of skin necrosis that is being managed with conservative wound care.The physician confirmed surgical debridement was not required.A device evaluation of the activ.A.C.¿ therapy system is currently pending completion.

Event Description

The activ.A.C.¿ therapy unit serial number (b)(4) is a customer owned device.The last quality control checklist performed by kci was in jun-2014.The facility provided their internal quality control checks and the device met the required specifications on 22-oct-2019 prior to placement with the patient.The facility noted that the device experienced pressure fluctuation during post placement quality control checks.The range of fluctuation was not provided to kci.The facility confirmed the equipment used to test the device functionality was in calibration at the time of the quality control checks.The device was returned to kci and the pressure modules were repaired.The contribution of the alleged pressure fluctuation to the alleged dermal bruising, flap compromise and necrosis is indeterminate based on the information gathered during the kci device repair.

Manufacturer Narrative

Based on the information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged dermal bruising, skin flap compromise, and necrosis are related to activ.A.C.¿ therapy.

• Brand Name: ACTIV.A.C.¿ THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• MDR Report Key: 8112197
• MDR Text Key: 128728293
• Report Number: 3009897021-2018-00106
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K063692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: WNDACC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2018
• Date Manufacturer Received: 09/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other