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 08/16/2022

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged hemorrhage is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient underwent a debridement prior to the event and was also noted to be on blood thinners.The device passed quality control checks before and after patient placement.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.

Event Description

On 19-aug-2022, the following information was provided to kci by the patient: the patient was on blood thinners and allegedly had a lot of bleeding, evident by filling 2 canisters in 30 minutes.The patient reported to the emergency room and the activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed.The patient is scheduled for graft surgery on (b)(6) 2022 and is uncertain if the activ.A.C.¿ ion progress¿ remote therapy monitoring system will be resumed.On 16-aug-2022 , the following information was provided to kci by the home health agency via fax: on (b)(6) 2022 the nurse noted wound v.A.C.® not in place upon arrival.The v.A.C.® was replaced earlier today at wound center.The dressing was noted to be filled with pooled blood and wound center staff instructed the patient to remove the v.A.C.®.The patient applied an alternate dressing and called home health to replace the v.A.C.®.The dressing in place was multiple levels, thick reinforcements with all levels saturated with bright red blood.The dressing was removed and cleansed with normal sterile saline.A small area, approximately 3 inches away from lower end of wound, with an area of blood oozing.Pressure applied for 8 minutes, and it stopped.Small pieces of aquacel silver applied as directed by wound care center.Covered with three pieces of v.A.C.® granufoam¿.Covered with v.A.C.® drape and attached the v.A.C.® at 125mmhg as per orders.When the v.A.C.® started, the tubing immediately filled with bright red drainage that traveled directly to the canister quickly.The nurse noted it seemed excessive.The v.A.C.® was paused and the physician was notified.The physician instructed to have the patient report to the emergency room with v.A.C.® intact.The nurse padded the car seat in case of leak and the wife transported the patient to the emergency room.The physician was to have his associate meet them there.The patient remained calm, and the vitals remain stable.The wife transported in personal vehicle.On (b)(6) 2022, the following information was provided to kci by the patient care manager: the patient stated the physician poked the wound with a q-tip prior to the event.The nurse pulled the dressing back and noted a large clot.She reapplied the v.A.C.® and the canister filled with blood.The patient reported to the emergency room where the wound was cauterized.On (b)(6) 2022, the following information was provided to kci by the patient: the physician was picking around and applied silver nitrate while at the wound care appointment.Upon returning home the patient noted blood under the v.A.C.® drape and in the tubing.The patient notified the wound clinic who instructed him to remove the v.A.C.® and call his home health agency.The patient stated after the nurse reapplied the dressing, 2 canisters were filled with blood by the time he reached the emergency room, within a 30min span.He stated the area was cauterized and he did not require a blood transfusion.On (b)(6) 2022, the following information was provided to kci by the wound care clinic nurse: the nurse that saw the patient that day was an agency nurse and is no longer available.The patient did undergo a debridement prior to the event and was also noted to be on blood thinners.No further information provided.Per review of kci records: on (b)(6) 2022 the patient presented to the emergency room and was evaluated for treatment of onset of right thigh hematoma status post bike injury a week ago.The patient is on plavix and coumadin for chronic hypercoagulable state.The patient has a complex vascular history status post multiple intervention for aortic dissection and subsequent complications from that.The patient was riding his bike a week ago and suffered an injury to the right thigh but did not seek any attention or stop his coumadin.Earlier last night the patient developed acute onset of severe swelling and pain in the thigh presented to the er.Patients inr was found to be at 2.6.A computed tomography angiogram of the leg showed moderate to large hematoma in the lateral thigh with possible extravasation of dye indicative of active bleed.The patient was statically stable.The patient had full use and function of the right leg.On 29-aug-2022, a device evaluation was completed by kci quality engineering.On 25-jul-2022, 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) 2022, the device was placed with the patient.On 24-aug-2022, the device was tested per quality control procedure by kci 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.

Manufacturer Narrative

Mdr-3009097021-2022-00138 submitted on 09-sep-2022 noted the following: section b5: describe event or problem: on 24-aug-2022, the device was tested per quality control procedure by kci service center, and the unit passed the quality control checks and met specifications.Correction: section b5: describe event or problem: on 26-aug-2022, the device was tested per quality control procedure by kci service center, and the unit passed the quality control checks and 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 78249
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 15390886
• MDR Text Key: 299563387
• Report Number: 3009897021-2022-00138
• 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: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• 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 Returned to Manufacturer: 08/24/2022
• Date Manufacturer Received: 08/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• 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: CLOPIDOGREL BISULFATE 75 MG ORAL TABLET.; ENTRESTO 49-61 MG ORAL TABLET.; HYALURONIC ACID 20-60 MG ORAL CAPSULE.; METOPROLOL SUCCINATE ER 50 MG ORAL TABLET EXTENDED.; MULTIVITAMIN FOR HIM ORAL CAPSULE.; PRAMIPEXOLE 0.5 MG TABLET.; PRAMIPEXOLE DIHYDROCHLORIDE 0.5 MG ORAL TABLET.; TAMSULOSIN HCL 0.1 MG ORAL CAPSULE.; WARFARIN SODIUM 4 MG ORAL TABLET.; WARFARIN SODIUM 6 MG ORAL TABLET.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male