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 Bacterial Infection (1735); Unspecified Infection (1930); Fluid Discharge (2686)

Event Date 05/12/2020

Event Type  Injury  

Manufacturer Narrative

Based on the information available by (b)(6) 2020, it could not be determined that the alleged event was related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient was being treated for wide resection left buttock necrotic tumor.Additionally, the patient had been on long term antibiotics and chemo medication and is immunosuppressed.Based on the additional information obtained on 03-feb-2021, the nurse clarified the green drainage and odor 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 03-feb-2021.A device evaluation is currently pending completion.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.Dressing changes wounds being treated with the v.A.C.® therapy system should be monitored on a regular basis.In a monitored, non-infected wound, v.A.C.® dressings should be changed every 48-72 hours, but no less than 3 times a week, with frequency adjusted by the clinician as appropriate.Infected wounds must be monitored often and very closely.For these wounds, dressings may need to be changed more often than 48-72 hours; the dressing changing intervals should be based on a continuing evaluation of the wound condition and the patient's clinical presentation, rather than a fixed schedule.

Event Description

On 15-may-2020, the following information was reported to kci by the patient: on (b)(6) 2020, the home health nurse did not reapply the activ.A.C.¿ ion progress¿ remote therapy monitoring system alleging green drainage and odor.The physician was notified regarding a need for a culture.The physician instructed the home health agency to reapply the activ.A.C.¿ ion progress¿ remote therapy monitoring system on (b)(6) 2020.On 03-feb-2021, the following information was reported to kci by the home health nurse: the alleged green drainage and odor were unrelated to activ.A.C.¿ ion progress¿ remote therapy monitoring system per kci records, v.A.C.® therapy was discontinued on (b)(6) 2020.On (b)(6) 2021, a device history record review for the v.A.C.® granufoam¿ dressing lot number 7536883v007 was completed.All end release testing of product and packaging met specifications a device evaluation of the activ.A.C.¿ therapy system is currently pending completion.

Event Description

On 03-feb-2021, the following information was reported to kci by the home health nurse: the alleged green drainage and odor were unrelated to activ.A.C.¿ ion progress¿ remote therapy monitoring system.The results of the culture were inaccessible.No additional information available.An evaluation of the device is not required as the event is unrelated to v.A.C.® therapy.

Manufacturer Narrative

Mdr-3009897021-2021-00019 submitted on 12-feb-2021 noted the following: b3 date of event: (b)(6) 2020.B5 describe event or problem: on 03-feb-2021, the following information was reported to kci by the home health nurse: the alleged green drainage and odor were unrelated to activ.A.C.¿ ion progress¿ remote therapy monitoring system.A device evaluation of the activ.A.C.¿ therapy system is currently pending completion.B7 other relevant history, including preexisting medical conditions: pre-existing medical conditions: hypertension, breast cancer.G3 date received by manufacturer: 12-mar-2020.G6 type of report: 30-day and initial.H3 device evaluated by manufacturer: no: device evaluation anticipated, but not yet begun.H6 adverse event problem: health effect - clinical code: 1735; type of investigation: 10; investigation findings: 3233; investigation conclusions: 11.H10: additional manufacturer narrative: based on the information available by 14-june-2020, it could not be determined that the alleged event was related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient was being treated for wide resection left buttock necrotic tumor.Based on the additional information obtained on 03-feb-2021, the nurse clarified that green drainage and odor 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 03-feb-2021.A device evaluation is currently pending completion.Corrections: b3 date of event: (b)(6) 2020.B5 describe event or problem: on 03-feb-2021, the following information was reported to kci by the home health nurse: the alleged green drainage and odor were unrelated to activ.A.C.¿ ion progress¿ remote therapy monitoring system.The results of the culture were inaccessible.No additional information available.An evaluation of the device is not required as the event is unrelated to v.A.C.® therapy.B7 other relevant history, including preexisting medical conditions: pre-existing medical conditions: hypertension, breast cancer, left buttock mass.G3 date received by manufacturer: 15-mar-2020.G6 type of report: 30-day.H3 device evaluated by manufacturer: no: other: evaluation of device not required h6 adverse event problem: health effect - clinical code: 1930 and 2686; type of investigation: 4111 and 3331; investigation findings: 213; investigation conclusions: 50.H10: additional manufacturer narrative: section h3: other (code unspecified, describe in h10): an evaluation of the device is not required as the event is unrelated to v.A.C.® therapy.Based on the information provided on 15-may-2020, kci could not determine that the alleged green drainage and odor were related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.On (b)(6) 2020, the patient underwent a wide resection of a necrotic tumor and v.A.C.® therapy was initiated.The patient is immunosuppressed and has been on long term antibiotic therapy and chemo medication.As of 14-jun-2020, kci did not have information to exclude that an infection was confirmed or if medical or surgical intervention was required.Based on the additional information obtained on 03-feb-2021, the nurse confirmed the green drainage and odor were unrelated to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Therefore, kci has deemed this event not reportable.

• 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: 11325755
• MDR Text Key: 238720583
• Report Number: 3009897021-2021-00019
• 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: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• 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: 7536883V007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2020
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AMOXICILLIN 500 MG 4 CAPSULES ORALLY 1 HOUR PRIOR; AYR SALINE 0.65% NASAL GEL 2 SPRAYS NASAL 2 TIMES; CIPRO 500 MG 1 TAB ORALLY 2 TIMES A DAY; DEXAMETHASONE 0.5 MG/5 ML 10 MILLILITER ORALLY 4 T; ESSENTIAL OILS ADDED TO HER WATER; EVEROLIMUS 5 MG 1 TAB ORALLY ONCE A DAY; FLAGYL 500 MG 1 TAB ORALLY EVERY 8 HOURS; LOMOTIL 2.5 MG 1-2 TABS ORALLY 4 TIMES A DAY AS NE; LOMOTIL 2.5 MG 2 TABS ORALLY EVERY 6 HOURS AS NEED; METFORMIN 500 MG 1 TAB ORALLY 2 TIMES A DAY; OMEPRAZOLE 20MG ORAL DELAYED RELEASE TABLET 1 TAB; PREVIDENT 5000 PLUS TOPICAL CREAM APPLY TOPICALLY
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 46