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

Model Number WNDARM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Failure of Implant (1924)

Event Date 04/18/2022

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged graft failure is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Per the nurse on (b)(6) 2022, there was no documentation noting graft and/or graft failure; however, additional information received from a separate nurse on (b)(6) 2022 indicated the graft failed on 18-apr-2022.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is pending completion.Device labeling, available in print and online, states: continuous therapy is also generally recommended for patients at increased risk of bleeding, highly exudating wounds, fresh flaps and grafts, and wounds with acute enteric fistulae.Continuous therapy for duration of 7 days with no dressing changes is also generally recommended for use of v.A.C.® therapy with a new graft placement.Apply v.A.C.® dressing immediately after graft placement and begin therapy as soon as possible.When using v.A.C.® granufoam¿ dressings, a non-adherent dressing should be placed directly over the graft / tissue.In general, the pressure setting used to prepare the recipient bed before grafting should be continued after grafting.Continuous therapy should be used to provide a constant bolster.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.

Event Description

On 05-may-2022, the following information was reported to kci by the patient's family member: the patient allegedly developed a wound infection.The wound allegedly had a strong odor and was discolored brown and yellow.The patient was placed on an alternate dressing and completed prescribed antibiotics.The patient had a shark graft that allegedly failed and continued to use the activ.A.C.¿ ion progress¿ remote therapy monitoring system but continued to change the v.A.C.® dressing once a week.The family member requested the v.A.C.® dressing be changed more often (3 times per week).The patient is scheduled to resume v.A.C.® therapy next week.On (b)(6) 2022, the following information was reported to kci by the nurse: on (b)(6) 2022, the nurse practitioner noted the patient developed a deep vein thrombosis in her left leg after knee surgery and prolonged time in external fixator.Left lower extremity wound irrigated and debrided with integra® replacement wound v.A.C.® application on (b)(6) 2022 noted.The patient was ambulating with a walker and denied fever and/or chills.A foul-smelling odor was noted to be coming from the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The left anterior shin wound v.A.C.® was noted to be in place with a large of amount of foul-smelling drainage present under integra®.The integra® was removed, and an alternate dressing was applied.On (b)(6) 2022, the odor was noted to be coming from the activ.A.C.¿ ion progress¿ remote therapy monitoring system.No documentation noted of a wound culture and no documentation noted of a graft and/or graft failure.She stated the physician assistant was not available for further information or clarification.No additional information was provided.On (b)(6) 022, the following information was reported to kci by the nurse: on (b)(6) 2022, the patient's graft failed and was started on antibiotic therapy on (b)(6) 2022.On (b)(6) 2022, during office visit, there was no foul odor, therefore no infection present, with decreased maceration.The nurse was unable to verify if the activ.A.C.¿ ion progress¿ remote therapy monitoring system had any relationship to either event and left notice for the physician regarding inquiry of the causative effects between the activ.A.C.¿ ion progress¿ remote therapy monitoring system and the graft failure and infection.Review of kci records received (b)(6) 2022: the patient was noted to be a high risk for infection and prior history of delayed wound healing with presence of co-morbidities.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending completion.The alleged infection is reported under mdr-3009897021-2022-00107.

Manufacturer Narrative

Based on the additional information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged graft failure is related to activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks before patient placement, and no failures were found with the device related to this event after placement.

Event Description

On 15-jun-2022, a device evaluation was completed by kci quality engineering.On 06-apr-2022, the device was tested per quality control procedure by kci service center, and the unit passed the quality control checks and met specifications.On (b)(6) 2022, the device was placed with the patient.On 09-jun-2022, the device was tested per quality control procedure by kci quality engineering and no failures were found with the device related to this event.

• Brand Name: ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC; san antonio TX 78249
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 14595490
• MDR Text Key: 293307986
• Report Number: 3009897021-2022-00115
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDARM
• Device Catalogue Number: 416909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 06/15/2022
• Supplement Dates FDA Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN 500MG TAB BY MOUTH AS NEEDED; APIXABAN 2.5 MG TAB ORAL 2 TIMES DAILY; CIPROFLOXACIN HCL 0.3% OPHTH SOL 5 ML TWICE DAILY; CLOBETASOL 0.05% OINT. TOPICALLY DAILY TO WOUND BE; DAKIN'S SOL APPLY TOPICALLY DAILY TO WOUND BED; LIDOCAINE 2% APPLY TO AFFECTED AREA DAILY AS NEEDE; LIDOCAINE 4% SOL 10-15 MIN PRIOR TO DRESSING CHANG; METHYLPHENIDATE HCL 36MG CR TAB ORAL EVERY MORNING; TIMOLOL 0.5% OPHTH SOL APPLY DROPS TO WOUND BED DA; VIT D2 1250 MCG TAKE 50,000 UNITS EVERY MONDAY
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Sex: Female