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 01/26/2024

Event Type  Injury  

Event Description

On 30-jan-2024, the following information was provided to kci by the patient: the patient was discharged from the hospital on (b)(6) 2024 with the activ.A.C.¿ ion progress¿ remote therapy monitoring in place.He returned to the hospital 3 hours later due to a blockage alarm and the wound allegedly bleeding excessively.The wound allegedly had to be cauterized.The activ.A.C.¿ ion progress¿ remote therapy monitoring was replaced on (b)(6) 2024 and he was discharged home on (b)(6) 2024.On 19-feb-2024, the following information was provided to kci by the nurse: the patient was seen in the clinic for a follow-up appointment on (b)(6) 2024.There was no documentation about emergency room visit on (b)(6) 2024, so she is unsure about the bleeding event and the alleged cauterization.No additional information was provided.On 22-jan-2024, the device was tested per quality control procedure by a kci service center, and the unit passed the quality control checks and met specifications.On (b)(6) 2024, the device was placed with the patient.On (b)(6) 2024, the device was tested per quality control procedure by a 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

Based on the information provided, it cannot be determined that the alleged bleeding event requiring cauterization is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient is on anticoagulation therapy.Multiple unsuccessful attempts have been made to obtain additional clinical information.The device met specifications 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.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

Mdr-3009897021-2024-00009 submitted on 27-feb-2024 noted the following: section a1 patient identifier: (b)(6).Correction: section a1 patient identifier: (b)(6).

• 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 ; 2102556436
• MDR Report Key: 18788972
• MDR Text Key: 336399473
• Report Number: 3009897021-2024-00009
• Device Sequence Number: 1
• Product Code: OMP
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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: 02/03/2024
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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 PO DAILY; ATORVASTATIN 80MG PO DAILY; CELEBREX 200MG PO DAILY; CLOPIDOGREL 75MG PO DAILY; DULOXETINE 60MG PO DAILY; INSULIN LISPRO 36 UNITS SQ TID WITH MEALS; JARDIANCE 25MG PO QAM; LANTUS 70UNITS SQ Q12HRS; OXYCODONE 5MG PO Q6HRS PRN; PREGABALIN 50 MG PO TID
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male