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); Skin Irritation (2076)

Event Date 02/29/2020

Event Type  Injury  

Manufacturer Narrative

Unique identifier (udi) # for v.A.C.® granufoam¿ dressing lot number 7171883v009: (b)(4).Based on information provided, it cannot be determined that the alleged hospitalization and infection are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Kci has made multiple unsuccessful attempts to obtain additional clinical information.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 03-mar-2020, the following information was reported to kci by the patient: on 29-feb-2020, the activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed allegedly due to irritation and pus noted around the wound and the patient was admitted to the hospital for a couple of days.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 7171883v009 is currently pending completion.

Manufacturer Narrative

Additional information for v.A.C.® granufoam¿ dressing lot number 7171883v009: section d4 expiration date: 30-sep-2022.Section h4 device manufacture date: 22-oct-2019.Based on the additional information obtained regarding the device and the v.A.C.® granufoam¿ dressing, kci's assessment remains the same: it cannot be determined that the alleged hospitalization and infection are related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.Mdr-3009897021-2020-0142 submitted on 02-apr-2020 reported the following: g1: email:(b)(4).Correction: g1: email:(b)(4).

Event Description

On 11-feb-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 10-apr-2020, 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.On 17-apr-2020, a device history record review for v.A.C.® granufoam¿ dressing lot number 7171883v009 was completed.All end release testing of product and packaging met specifications.

• Brand Name: ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC; san antonio, tx
• MDR Report Key: 9919248
• MDR Text Key: 188565437
• Report Number: 3009897021-2020-00142
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• PMA/PMN Number: K063692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

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 Lot Number: 7171883V009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2020
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 04/02/2020
• Supplement Dates Manufacturer Received: 04/17/2020
• Supplement Dates FDA Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 51 YR