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 Tissue Breakdown (2681); Patient Problem/Medical Problem (2688)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Unique identified (udi) for v.A.C.® granufoam¿ dressing lot number 7848884v009: (b)(4).Unique identified (udi) for activ.A.C.¿ canister lot number 7666897v009: (b)(4).Based on information provided, it cannot be determined that the alleged wound appearance and potential amputation were related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.An amputation was not confirmed and it is unknown if the medical or surgical intervention was required.Kci has made multiple unsuccessful attempts to obtain additional clinical information.Device labeling, available in print and online, states: precautions the v.A.C.® therapy system will not be effective in addressing complications associated with the following: untreated or inadequately treated infection.Cellulitis of the incision area.Indicators of ineffective therapy.Minimal changes in wound size.When there is little or no change in the wound for one to two consecutive weeks, and patient compliance, technique and underlying co-morbidities are not the cause, the following may be useful: cut the foam slightly smaller than the wound edges for wounds with little depth, to enhance inward epithelial migration.Do not allow the wound edges to roll downward during v.A.C.® therapy.Deterioration of the wound if a wound has been progressing well from dressing change to dressing change but then deteriorates rapidly, consider the following interventions and, where necessary, seek the guidance / expertise of a specialist: if available on the therapy unit, check the therapy history log to ensure that the actual number of therapy hours received matches the number of recommended therapy hours (22 hours a day).If the number of hours is less than 22 each day, find out why there is a therapy deficit and remedy the situation.Clean wound more thoroughly during dressing changes.Evaluate for signs and symptoms of infection and, if present, treat accordingly.Change dressing often, ensuring that it is being changed at least every 48 hours.Examine the wound and debride as necessary.Debride the wound edges if they appear non-viable or rolled under as this may inhibit the formation of granulation tissue and migration of epithelial cells over an acceptable wound base.

Event Description

On (b)(6) 2020, the following information was reported to kci by the patient's support person: the physician was allegedly not satisfied with the appearance of the patient's wound.The patient may need an amputation.On (b)(6) 2020, the following information was reported to kci by the patient: the activ.A.C.¿ ion progress¿ remote therapy monitoring system was allegedly removed over a week ago and v.A.C.® therapy was not resumed.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is currently pending completion.Device history record reviews for v.A.C.® granufoam¿ dressing lot number 7062886v009 and activ.A.C.¿ canister lot number 7666897v009 are currently pending completion.

Manufacturer Narrative

Mdr 3009897021-2020-00346 submitted on 31-jul-2020 noted the following: b5 describe event or problem noted v.A.C.® granufoam¿ dressing lot number 7062886v009.Correction: b5 describe event or problem should be v.A.C.® granufoam¿ dressing lot number 7848884v009.Additional information for v.A.C.® granufoam¿ dressing lot number 7848884v009: d4 expiration date: 28-feb-2023.H4 device manufacture date: 23-mar-2020.Additional information for activ.A.C.¿ canister lot number 7666897v009: d4 expiration date: 31-jan-2023.H4 device manufacture date: 25-feb-2020.Based on the additional v.A.C.® granufoam¿ dressing and activ.A.C.¿ canister information provided, kci's assessment remains the same; it cannot be determined that the alleged wound appearance and potential amputation were related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.

Event Description

On 06-aug-2020, device history record reviews for activ.A.C.¿ canister lot number 7666897v009 and v.A.C.® granufoam¿ dressing lot number 7848884v009 were completed.All end release testing of the product and packaging met specifications.

Event Description

On (b)(6) 2020, kci quality engineering completed an evaluation of the device.On (b)(6) 2020, 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) 2020, the device was placed with the patient.On (b)(6) 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.

Manufacturer Narrative

Based on additional information obtained regarding the device, kci's assessment remains the same; it cannot be determined that the alleged wound appearance and potential amputation were related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.An amputation was not confirmed and it is unknown if the medical or surgical intervention was required.The device 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
• MDR Report Key: 10353245
• MDR Text Key: 209150713
• Report Number: 3009897021-2020-00346
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• 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: 7848884V009;7666897V009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Date Manufacturer Received: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPERCREME; GLUCOTROL; PRINIVIL
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 71