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); Drug Resistant Bacterial Infection (4553)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

Additional information for v.A.C.® granufoam¿ dressing lot number 8888885v009: expiration date: 30-nov-2023.Unique identifier (udi) #: (b)(4).Based on the information provided, it cannot be determined that the alleged infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The nurse stated that the infection may have been caused by the activ.A.C.¿ ion progress¿ remote therapy monitoring system.No additional information was provided.Based on the information provided, it cannot be determined that the alleged infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The nurse stated that the infection may have been caused by the activ.A.C.¿ ion progress¿ remote therapy monitoring system.No additional information was provided.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.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.Precautions: the v.A.C.® therapy system will not be effective in addressing complications associated with the following: ischemia to the incision or incision area.Untreated or inadequately treated infection.Inadequate hemostasis of the incision.Cellulitis of the incision area.

Event Description

On 08-mar-2021, the following information was reported to kci by the patient: the patient reported she was placed on an alternate dressing allegedly due to an infection.The patient stated she was staying off the activ.A.C.¿ ion progress¿ remote therapy monitoring system pending hernia repair surgery scheduled on (b)(6) 2021.On 12-mar-2021, the following information was reported to kci by the nurse: the nurse stated that the infection may have been caused by the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Additionally, the pending hernia repair surgery was unrelated to v.A.C.® therapy.No additional information was provided.On 07-apr-2021, the following information was reported to kci by the nurse: the nurse stated that the infection was diagnosed as mrsa on (b)(6) 2021.She stated she do not know how the infection was resolved.A device evaluation for activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending completion.A device history record review for v.A.C.® granufoam¿ dressing lot number 8888885v009 is currently pending completion.

Event Description

On (b)(6) 2021, a device history record review for v.A.C.® granufoam¿ dressing lot number 8888885v009 was completed.All end release testing of the product and packaging met specifications.On (b)(6) 2021, kci quality engineering completed an evaluation of the device.On (b)(6) 2021, the device was tested per quality control procedure by kci service center, and the unit passed the quality control checks and met specifications before patient placement.On (b)(6) 2021, the device was placed with the patient.On (b)(6) 2021, the device was tested per quality control procedure by kci quality engineering 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

Mdr- 3009897021-2021-00061 submitted on 07-apr-2021 noted the following: section h6: adverse event problem health effect - clinical code: 1930.Section h10: additional manufacturer narrative: based on the information provided, it cannot be determined that the alleged infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The nurse stated that the infection may have been caused by the activ.A.C.¿ ion progress¿ remote therapy monitoring system.No additional information was provided.Based on the information provided, it cannot be determined that the alleged infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The nurse stated that the infection may have been caused by the activ.A.C.¿ ion progress¿ remote therapy monitoring system.No additional information was provided.Section h6 adverse event problem health effect - clinical code: 4553.Section h10 additional manufacturer narrative: based on the information provided, it cannot be determined that the alleged infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The nurse stated that the infection may have been caused by the activ.A.C.¿ ion progress¿ remote therapy monitoring system.An evaluation of the activ.A.C.¿ therapy system is currently pending completion.Additionally, the nurse confirmed the hernia repair surgery was unrelated to v.A.C.® therapy; therefore, kci has determined the surgery as not reportable.Additional information for v.A.C.® granufoam¿ dressing lot 8888885v009: h4: device manufacture date: 20-dec-2020.Based on the corrections and additional information received regarding the device and the v.A.C.® granufoam¿ dressing, kci's assessment remains the same; the alleged hernia repair is unrelated to v.A.C.® therapy and is considered not reportable.However, kci cannot determine that the alleged infection is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device history record review for the v.A.C.® granufoam¿ dressing met specifications and the activ.A.C.¿ therapy system passed quality control checks before and after patient placement.

• 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
• MDR Report Key: 11631646
• MDR Text Key: 261307861
• Report Number: 3009897021-2021-00061
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• PMA/PMN Number: K201571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• 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
• Device Lot Number: 8888885V009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN 500 MG; AMLODIPINE 10 MG; AMOXICILLIN-CLAVULANATE 875 MG; ATORVASTATIN 40 MG; DOCUSATE SODIUM 100 MG; DULOXETINE 60 MG; ENOXAPARIN 40 MG; GABAPENTIN 300 MG; INSULIN; LEVOTHYROXINE 125 MCG; MELOXICAM 7.5 MG
• Patient Outcome(s): Other
• Patient Age: 69 YR