MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. ACTIV.A.C.¿ ION PROGRESS¿ REMOTE THERAPY MONITORING SYSTEM; OMP

Model Number WNDARM

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/04/2022

Event Type  Injury  

Event Description

On 14-nov-2022, the following information was provided to kci by the patient's spouse: on (b)(6) 2022, the home health nurse was changing the v.A.C.® dressing and allegedly indicated the patient's wound was bleeding.After applying direct pressure to stop the active bleeding, the nurse reapplied the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The nurse suggested that the spouse consult with the physician about cauterizing the wound at patient's upcoming appointment on (b)(6) 2022.From that point forward, the canisters were allegedly filled with blood.On 10-nov-2022, the nurse arrived for the first time since the previous visit on (b)(6) 2022, and the canisters that were full of blood were shown to the nurse.The nurse called emergency medical services for transport to the hospital, and the patient is currently admitted and allegedly received a blood transfusion.The anticoagulation therapy, eliquis and aspirin, have been placed on hold.On 18-nov-2022, the following information was provided to kci by the medical assistant: the physician indicated that the patient's bleeding event that led to medical intervention was caused by the patient being on blood thinners and v.A.C.® therapy being placed back on the patient instead of a wet to dry dressing.There was a breakdown in communication within the healthcare team and the physician was not notified that the patient had active bleeding.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is pending completion.

Manufacturer Narrative

Based on the information provided, it cannot be determined that the alleged bleeding event requiring hospitalization and a blood transfusion is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient is on anticoagulation therapy and has a history of significant bleeding that required cauterization prior to v.A.C.® therapy placement.The home health nurse noted active bleeding and reapplied the activ.A.C.¿ ion progress¿ remote therapy monitoring system without notifying the physician, which is outside of the manufacturer's recommendations.Therefore, this event is being reported due to potential use error.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring system is pending completion.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 information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged bleeding event requiring hospitalization and a blood transfusion is 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.The home health nurse noted active bleeding and reapplied the activ.A.C.¿ ion progress¿ remote therapy monitoring system without notifying the physician, which is outside of the manufacturer's recommendations.Therefore, this event is being reported due to potential use error.

Event Description

On 05-jan-2023, a device evaluation was completed by kci quality engineering.On 13-oct-2022, the device was tested per quality control procedure by kci service center, and the device passed and met specifications.On 21-oct-2022, the device was placed with the patient.On 04-jan-2023, the device was tested per quality control procedure by kci service center and the device passed 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
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 15958807
• MDR Text Key: 305256066
• Report Number: 3009897021-2022-00179
• 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
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• 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: 11/17/2022
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2021
• 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: ASPIRIN 81 MG DAILY; ATORVASTATIN 40 MG AT BEDTIME; BACLOFEN 5 MG AT BEDTIME; DOCUSATE SODIUM 100 MG TWO TIMES PER DAY; DUONEB 0.5MG-3MG/3ML SOL VIA NEB EVERY 6 HRS PRN; ELIQUIS 5 MG TWO TIMES PER DAY; FEBUXOSTAT 40 MG DAILY; FERROUS SULFATE 300 MG TWO TIMES PER DAY; KEPPRA 1500 MG TWO TIMES PER DAY; LISPRO INSULIN 100 UNITS/ML PER SLIDING SCALE; LYRICA 25 MG EVERY 8 HOURS; METOPROLOL TARTRATE 150 MG TWO TIMES PER DAY; MIRALAX 17 GM DAILY AS NEEDED; MULTIVITAMIN WITH MINERAL DAILY; OMEGA 3 FATTY ACIDS 2000MG TWO TIMES A DAY; PRILOSEC 20 MG DAILY; VALSARTAN 40 MG TWO TIMES PER DAY; VITAMIN C 500 MG TWO TIMES PER DAY
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male