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 Problems Gangrene (1873); Necrosis (1971)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

Based on the information provided on 13-jul-2017, kci is reporting this event due to the patient's report of experiencing a toe amputation, however, as of 12-aug-2017, kci had no indication from the information provided to suggest that the activ.A.C.¿ ion progress¿ remote therapy monitoring system caused, or contributed to the amputation.The patient had a history of gangrene, toe amputation, and debridements.Kci could not determine that the alleged event was related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Based on the additional information obtained on 28-jun-2018, the nurse confirmed that the amputation reported by the patient on (b)(6) 2017 was unrelated to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Kci has deemed this event not reportable based on the information received on 28-jun-2018.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.

Event Description

On (b)(6) 2017, the following information was reported to kci by the patient: on (b)(6) 2017, the patient underwent a toe amputation.The activ.A.C.¿ ion progress¿ remote therapy monitoring system was placed on hold.No additional information was available.On 28-jun-2018, the following information was reported to kci by the nurse, "the activ.A.C.¿ ion progress¿ remote therapy monitoring system did not cause or contribute to the patient's amputation." per review of records: on (b)(6) 2017, the physician noted on (b)(6) 2017, the patient underwent an incision and drainage with amputation of the right hallux at the metatarsophalangeal joint level with a diagnosis of osteomyelitis, gas gangrene, diabetic foot infection.He also noted the, "patient will likely require serial debridements in the future." on (b)(6) 2017, the patient underwent a resection of distal half of the 1st metatarsal right foot, excision of the plantar sesamoid bones, and resection of gangrenous tissue.On (b)(6) 2017, the wound care center nurse noted there was no eschar present, and the patient underwent a debridement.On (b)(6) 2017, the wound care center nurse noted the patient was observed on (b)(6) 2017, which exhibited a decrease in the wound length, width and depth with no eschar, and the patient underwent a debridement.On (b)(6) 2017, the nurse reported, "to place vac on hold starting 14-jul-2017 per doctor's orders." on (b)(6) 2017, the physician's discharge orders noted activ.A.C.¿ ion progress¿ remote therapy monitoring system was discontinued on 26-jul-2017 due to a surgical wound related procedure.On 29-jun-2018, kci quality engineering confirmed the activ.A.C.¿ ion progress¿ remote therapy monitoring system was a new unit ,and had passed the quality control checks and met specifications prior to patient placement.On (b)(6) 2017, the device was placed with the patient.On (b)(6) 2017, the activ.A.C.¿ ion progress¿ remote therapy monitoring system underwent a retrofit unrelated to the customer complaint.The device was subsequently tested per quality control procedure by kci field service and the unit passed the quality control checks and met specifications.The activ.A.C.¿ ion progress¿ remote therapy monitoring system has since been placed with multiple subsequent patients.

• Brand Name: ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; 6203 farinon drive; san antonio, tx
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, tx ; 2556438
• MDR Report Key: 10488143
• MDR Text Key: 214147575
• Report Number: 3009897021-2020-00343
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/02/2020

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Initial Date Manufacturer Received: 07/13/2017
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR