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

Model Number WNDARM

Device Problems No Audible Alarm (1019); Alarm Not Visible (1022); Suction Problem (2170)

Patient Problem Failure of Implant (1924)

Event Date 01/20/2023

Event Type  Injury  

Event Description

On 23-jan-2023, the following information was provided to kci by the nurse: the activ.A.C.¿ ion progress¿ remote therapy monitoring system allegedly malfunctioned, did not alarm, and the patient's skin graft failed.The physician indicated the device kept the wound too wet.On 09-feb-2023, the following information received via clinical records from physician were reviewed: on 17-jan-2023, patient underwent skin grafting.The activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed (b)(6) 2023.Appeared the graft partially took.The wound bed appeared too moist and there is question as to if the activ.A.C.¿ therapy system was working properly.The wound bed is clean without signs of infection.New activ.A.C.¿ ion progress¿ remote therapy monitoring system delivered to patient home to be restarted at wound clinic.Will follow up to discuss repeat skin grafting.On 10-feb-2023, the following information was provided to kci by the nurse: v.A.C.® therapy was restarted (b)(6) 2023.Patient's wound is improving.On 20-feb-2023 a device evaluation was completed by kci quality engineering.On 08-dec-2022, the device was tested per quality control procedure by the kci service center, and the unit passed the quality control checks and met specifications.On (b)(6) 2023, the device was placed with the patient.On 20-feb-2023, the device was tested per quality control procedure by the kci service center, and the unit passed the quality control checks and met specifications.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.

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.The device passed quality control checks before and after patient placement.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.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a kinetic concepts, inc.Product malfunctioned, is defective or has caused serious injury.

• 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: 16408474
• MDR Text Key: 309914684
• Report Number: 3009897021-2023-00013
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2023
• 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: 420095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2021
• 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: NALOXONE HCL 4MG/0.1ML NASALLY AS NEEDED.; OXYCODONE 20MG EVERY 4 HRS AS NEEDED.
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Weight: 99 KG