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 Unspecified Infection (1930); Pressure Sores (2326)

Event Date 01/15/2021

Event Type  Injury  

Manufacturer Narrative

The specific date of the event is unknown.Date of alleged technical issues occurred on (b)(6) 2021.Based on information provided, it cannot be determined that the alleged infection and new wound are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient has a known history of infection as well as other comorbidities that could potentially contribute to an infection.It is unknown if an infection was confirmed via culture.The nurse previously identified a pressure point from the pressure fluctuating that allegedly caused a small mark on (b)(6) 2021, v.A.C.® therapy was placed on hold and subsequently re-applied.The physician did not provide clinical information regarding the alleged infection.The device passed quality control checks before and after patient placement.Device labeling, available in print and online, states: infected wounds should be monitored closely and may require more frequent dressing changes than non-infected wounds, dependent upon factors such as wound conditions, treatment goals, and instillation therapy parameters (for v.A.C.Instill® therapy system).Refer to dressing application instructions (found in v.A.C.® dressing cartons) for details regarding dressing change frequency.As with any wound treatment, clinicians and patients/caregivers should frequently monitor the patient's wound, periwound tissue and exudate for signs of infection, worsening infection, or other complications.Some signs of infection are fever, tenderness, redness, swelling, itching, rash, increased warmth in the wound or periwound area, purulent discharge or strong odor.Infection can be serious, and can lead to complications such as pain, discomfort, fever, gangrene, toxic shock, septic shock and/or fatal injury.Some signs or complications of systemic infection are nausea, vomiting, diarrhea, headache, dizziness, fainting, sore throat with swelling of the mucus membranes, disorientation, high fever, refractory and/or orthostatic hypotension or erythroderma (a sunburn-like rash).If there are any signs of the onset of systemic infection or advancing infection at the wound site, contact the treating physician immediately to determine if v.A.C.® therapy should be discontinued.Contraindications v.A.C.® therapy is contraindicated for patients with: untreated osteomyelitis.Note: if the wound is over a bony prominence or in an area where weight bearing may exert additional pressure or stress to the underlying tissues, a pressure-relief surface or device should be used to optimize patient off-loading.Determine inf patient is adequately off-loading or if there is a potential for external pressure on the wound / dressing, which may cause the wound exudate to be forced onto the periwound skin.

Event Description

On 15-jan-2021, the following information was provided to kci by the nurse: the activ.A.C.¿ ion progress¿ remote therapy monitoring system allegedly experienced a technical issue that caused a pressure point from the v.A.C.® tubing.On (b)(6) 2021, the following information was provided to kci by the nurse: the pressure point from the v.A.C.® tubing was allegedly from the pressure fluctuating and a small mark was left on the patient's foot.On (b)(6) 2021, the following information was provided to kci by the patient: the activ.A.C.¿ ion progress¿ remote therapy monitoring system allegedly caused an infection in his wound due to the pressure of the disc drawing into the wound.The patient was reportedly hospitalized.The device was replaced (b)(6) 2021.On (b)(6) 2021, the following information was provided to kci by the physician: the activ.A.C.¿ ion progress¿ remote therapy monitoring system's pressure unexpectantly increased to 250mmhg repeatedly that caused the tubing to form a new ulceration to the lateral plantar foot.It was noted the patient was seen on a weekly / biweekly basis and the issue was identified upon dressing removal.It was noted that surgical debridement and primary closure of the opening were required to resolve the event.The injury site healed within three weeks.Per review of records, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was placed on v.A.C.Therapy hold on 15-jan-2021, and was re-applied on 21-jan-2021.The v.A.C.® granufoam¿ dressing lot number was not provided; therefore, a device history record review could not be performed.On 09-oct-2020, 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)2020, the device was placed with the patient.On 25-jan-2021, the device was tested per quality control procedure by kci service center and 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.

• 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: 11389185
• MDR Text Key: 243137685
• Report Number: 3009897021-2021-00039
• 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,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• 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: 01/21/2021
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2018
• 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): Hospitalization; Other
• Patient Age: 63 YR