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

Model Number WNDARM

Device Problem Pressure Problem (3012)

Patient Problem Unspecified Infection (1930)

Event Date 02/16/2022

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged wound infection requiring hospitalization is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient reported that he experienced issues with maintaining a seal and that the physician told him to remove the device.The home health agency reported that the last nursing visit was on (b)(6) 2022.The patient followed up with the physician on (b)(6) 2022 and the physician note indicated that the patient disconnected the device until further assistance could be obtained.It is not clear when the device was removed and if an alternate dressing was placed.The patient has multiple comorbidities to include diabetes, heart failure with chronic pulmonary edema, heart valve replacement surgery followed by the development of a right femoral pseudoaneurysm that required repair and multiple surgical debridements.The device passed quality control checks before and after placement.Device labeling, available in print and online, states: warning: keep v.A.C.® therapy on: never leave a v.A.C.® dressing in place without active v.A.C.® therapy for more than two hours.If therapy is off for more than two hours, remove the old dressing and irrigate the wound.Either apply a new v.A.C.® dressing from an unopened sterile package and restart v.A.C.® therapy, or apply an alternate dressing at the direction of the treating physician.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.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.Wound infection: call your doctor or nurse right away if you think your wound is infected or if the following symptoms develop or worsen: -you have a fever -your wound is sore, red or swollen -your skin itches or you have a rash or redness around the wound -the area around the wound feels very warm -you have pus or a bad smell coming from the wound.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 (b)(6) 2022, the following information was reported to kci by the patient: the patient had seal issues, and the doctor informed the patient to remove the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient did not remember the date and was in the hospital.The last activ.A.C.¿ ion progress¿ remote therapy monitoring system data transmission date was on (b)(6) 2022.On (b)(6) 2022, the following information was reported to kci by the hospital nurse: the patient was admitted for a groin infection.No additional information available.On (b)(6) 2022, the following information was reported to kci by the physician's practice manager: the physician indicated that he is uncertain if the wound infection was caused or contributed by the activ.A.C.¿ ion progress¿ remote therapy monitoring system, however, it was possible.On (b)(6) 2022, the physician noted in the patient's record that the unit was not holding suction and kept alarming.The patient disconnected the unit until he could get assistance.On (b)(6) 2022, the following information was reported to kci by the home health staff member: the last home nursing visit was on (b)(6) 2022.On (b)(6) 2022, the device was tested per quality control procedure by kci service center, and the device passed and met specifications.On (b)(6) 2022, the device was placed with the patient.On (b)(6) 2022, the device was tested per quality control procedure by kci service center 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: 13801439
• MDR Text Key: 292573008
• Report Number: 3009897021-2022-00060
• 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: 03/17/2022

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
• Device Catalogue Number: 416909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2019
• 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: ASPIRIN 325 MG DELAYED RELEASE, ONCE DAILY; BENAZEPRIL 5 MG ONCE DAILY; BISACODYL 5 MG DAILY; COUMADIN 2.5 MG DAILY; DOCUSATE SENNA 1 TAB TWICE PER DAY; FUROSEMIDE 40 MG DAILY; HUMALOG INSULIN PER SLIDING SCALE, FOUR TIMES/DAY; METOPROLOL TARTRATE 25 MG DAILY; METOPROLOL TARTRATE 50 MG TWICE DAILY; OXYCODONE 10 MG EVERY 6 HOURS AS NEEDED; OXYGEN 2 LITERS VIA NASAL CANNULA; SIMVASTATIN 20 MG DAILY; TRAZADONE 100 MG AT BEDTIME; VITAMIN C 500 MG DAILY
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 53 YR
• Patient Sex: Male