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 Problem Hemorrhage/Bleeding (1888)

Event Date 08/22/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the following information was provided to kci by the patient: patient was hospitalized on (b)(6) 2022 allegedly due to excessive bleeding from wound.Stated that blood was in the canister and through the v.A.C.® dressing.The cause of the bleeding was unknown.On 25-aug-2022, the following information was provided to kci by the nurse: the primary diagnosis for hospitalization was hemorrhaging from wound.There was no mention of the cause of bleeding.Stated that patient was discharged home (b)(6) 2022.No additional information available.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is pending receipt of the device.

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged bleeding event is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient has significant comorbidities that may be contributing factors in this event.A device evaluation is pending receipt of the device.Device labeling, available in print and online, states: contraindications.Do not place foam dressings of the v.A.C.® therapy system directly in contact with exposed blood vessels, anastomotic sites, organs, or nerves.Warnings: bleeding: with or without using v.A.C.® therapy, certain patients are at high risk of bleeding complications.The following types of patients are at increased risk of bleeding, which, if uncontrolled, could be potentially fatal: patients who have weakened or friable blood vessels or organs in or around the wound as a result of, but not limited to: suturing of the blood vessel (native anastomosis or grafts) / organ; infection; trauma; radiation; patients without adequate wound hemostasis; patients who have been administered anticoagulants or platelet aggregation inhibitors; patients who do not have adequate tissue coverage over vascular structures.If v.A.C.® therapy is prescribed for patients who have an increased risk of bleeding complications, they should be treated and monitored in a care setting deemed appropriate by the treating physician.If active bleeding develops suddenly or in large amounts during v.A.C.® therapy, or if frank (bright red) blood is seen in the tubing or in the canister, immediately stop v.A.C.® therapy, leave dressing in place, take measures to stop the bleeding and seek immediate medical assistance.The v.A.C.® therapy units and dressings should not be used to prevent, minimize or stop vascular bleeding.Protect vessels and organs: all exposed or superficial vessels and organs in or around the wound must be completely covered and protected prior to the administration of v.A.C.® therapy.Always ensure that v.A.C.® foam dressings do not come in contact with vessels or organs.Use a thick layer of natural tissue should provide the most effective protection.If a thick layer of natural tissue is not available or is not surgically possible, multiple layers of non-adherent dressing material may be considered as an alternative, if deemed by the treating physician to provide a complete protective barrier.If using non-adherent materials, ensure they are secured in a manner that will maintain their protective position throughout therapy.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.Disclaimer: this information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a kinetic concepts, inc.Product malfunctioned, is defective or has caused serious injury.

Manufacturer Narrative

Based on the additional information provided regarding the device, (b)(6) assessment remains the same; it cannot be determined that the alleged bleeding event is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient has significant comorbidities that may be contributing factors in this event.The device passed quality control checks and met specifications before and after placement with the patient.

Event Description

On 31-oct-2022, a device evaluation was completed by kci quality engineering.On (b)(6) 2022, the device was tested per quality control procedure by the kci service center, and the unit passed the quality control checks 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 (b)(6) service center 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.

• 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: 15462327
• MDR Text Key: 300359080
• Report Number: 3009897021-2022-00151
• 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,Followup
• Report Date: 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2022
• 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: 420095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2021
• 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: ASPRIN 81 MG 1 TAB PO DAILY.; CARVEDILOL 6.25MG 1 PO TWICE A DAY.; CHLORTHALIDONE 25MG - 12.5MG TWICE A DAY.; CHOLECALCIFEROL 25MCG ONE TABLET ONCE A DAY.; CYANOCOBALAMIN 1,000 MCG PO ONCE A DAY.; CYMBALTA 60MG ONE CAP PO ONCE A DAY.; HYDROCODONE-ACETAMINOPHEN 5-325MG 1-2 TABS.; INSULIN GLARGINE 50 UNITS EVERY NIGHT.; METFORMIN 500MG PO EVERY MORNING.; OMEPRAZOLE 40MG ONE CAP PO DAILY.; TAMSULOSIN 0.4MG ONE PO DAILY.
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 59 YR
• Patient Sex: Male