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 Abscess (1690); Paraplegia (2448)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged abscess and acute paraplegia are related to the activ.A.C." ion progress" remote therapy monitoring system.A device evaluation is currently pending completion.Device labeling, available in print and online, states: 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.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 09-sep-2021, the following information was reported to kci by the patient's family member: the patient is in the hospital for emergency surgery.The physician allegedly found an abscess along the patient's spine and performed surgery to clean it out.Stated the physician had trouble finding the cause of patient being sick and almost paralyzed.On 30-sep-2021, the following information was reported to kci by the physician assistant: there was an infection present, but whomever was caring for the wound failed to report it.The activ.A.C." ion progress" remote therapy monitoring system was placed on (b)(6) 2021 and the patient was following-up with the wound care clinic and a visiting nurse twice a week.The patient allegedly developed an epidural abscess and when positioned for emergency surgery on (b)(6) 2021, it was clear that there was purulent drainage coming from the wound so if there was infection present.Unfortunately, by the time it was found the patient was already in the emergency room with acute paraplegia from the abscess.The event was related to wound care management.The activ.A.C." ion progress" remote therapy monitoring system was being tended to by home care twice a week and the patient was physically, supposedly, going to the wound care clinic once a week.The patient is still hospitalized, has another wound vac in placed and is now healing.The patient's wound was debrided, washed out, but quickly led to a neurologic deterioration.On 30-sep-2021, the following information was reported to kci by the home health nurse: the wound had no signs or symptoms of infection, no swelling, no abscess noted, never had a lot of drainage and the wound was filling in.The patient reported the patient was being seen twice a week and often missed her wound care clinic appointments.Patient last seen (b)(6) 2021.No additional information was provided.A device evaluation of the activ.A.C." ion progress" remote therapy monitoring system is currently pending completion.

Manufacturer Narrative

Based on the additional information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged abscess and acute paraplegia are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The device passed quality control checks and met specifications before and after placement with the patient.

Event Description

On 03-nov-2021, a device evaluation was completed by quality engineering.On 04-aug-2021, 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) 2021, the device was placed with the patient.On 02-nov-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

(b)(4) submitted on 07-oct-2021 noted the following: b3 date of event: (b)(6) 2021.Correction: b3 date of event: (b)(6) 2021.

• 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: 12589865
• MDR Text Key: 275472200
• Report Number: 3009897021-2021-00243
• 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: Other,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2018
• 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
• Treatment: ARIPIPRAZOLE 5MG ORAL BY MOUTH DAILY; BUPIVACAINE 0.25% INJECTION ROUTE; CETIRIZINE 10MG ORAL DAILY; DOCUSATE SODIUM 100MG ORAL DAILY; ESCITALOPRAM OXALATE 10MG ORAL DAILY; FAMOTIDINE 20MG ORAL NIGHTLY; FUROSEMIDE 20MG ORAL DAILY AS NEEDED FOR SWELLING; INTEGRA 125-40-3MG ORAL WITH BREAKFAST; KEFLEX 750MG ORAL TWICE DAILY; LOSARTAN 100MG ORAL DAILY; LOSARTAN 25MG ORAL DAILY; MAGNESIUM 500MG ORAL DAILY; METFORMIN 1000MG ORAL WITH DINNER; MORPHINE ER 15MG ORAL EVERY 12 HRS; ONDANSETRON 4MG; OXYCODONE 10MG EVERY 8 HRS AS NEEDED FOR PAIN 10/2; OXYCODONE=ACETAMINOPHEN 10-325MG ORAL Q4HRS AS NEE; PANTOPRAZOLE 40MG ORAL DAILY; ROSUVASTATIN 10MG ORAL DAILY; TIZANIDINE 4MG ORAL EVERY 6 HRS; TRAZODONE 100MG 2 TABS ORAL DAILY; VITAMIN D3 50000 IU DAILY
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 94 KG