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 11/09/2022

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged bleeding event requiring hospitalization and transfusion is related to the activ.A.C.¿ ion progress¿ remote therapy monitoring system.The patient was on anticoagulant therapy.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 22-nov-2022, the following information was provided to kci by the patient: the activ.A.C.¿ ion progress¿ remote therapy monitoring system was removed allegedly due to bleeding from his wound.On (b)(6) 2022, the following information was provided to kci by the home health nurse: upon arriving at the patient's home, there was a pool of blood underneath the patient's foot.The nurse described the alleged bleeding event as shooting out of the wound.The nurse stated the patient was admitted to the hospital and received a blood transfusion.The nurse believed the bleeding event was due to the procedure done on (b)(6) 2022, but was not certain.On (b)(6) 2022, the following information was provided to kci by the triage nurse: the nurse confirmed the patient was hospitalized for bleeding and received a blood transfusion.No additional information was provided.On (b)(6) 2022, a device evaluation was completed by kci quality engineering.On (b)(6) 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 (b)(6) 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.

• 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: 15996101
• MDR Text Key: 305607967
• Report Number: 3009897021-2022-00177
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• 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: 11/30/2022
• Date Manufacturer Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2021
• 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: ALBUTEROL 90 MCG/ACTUATION INHALER, 2 PUFFS INHALE.; ALLOPURINOL 100 MG TABLETS, 1 TABLET BY MOUTH ONCE.; AMLODIPINE 5 MG TABLETS, 1 TABLET BY MOUTH ONCE DA.; ASPIRIN EC 81 MG TABLETS, 1 TABLET BY MOUTH ONCE D.; ATORVASTATIN 80 MG TABLETS, 40 MG TABLET BY MOUTH.; DULOXETINE 30 MG DELAYED RELEASE CAPSULE, 1 CAPSUL.; FLUTICASONE PROPIONATE 50 MCG/ACTUATION, 1 SPRAY I.; GABAPENTIN 300 MG CAPSULES, 1 CAPSULE BY MOUTH THR.; HYDROMORPHONE 2 MG TABLETS, 1 TABLET BY MOUTH EVER.; HYDROXYZINE 10 MG TABLETS, 1 TABLET BY MOUTH THREE.; INSULIN HUMAN U-100 NPH-REGULAR 70-30 MIX 100 UNIT.; ISOSORBIDE MONONITRATE CR 30 MG 24-HOUR TABLET, 1.; METOPROLOL XL 50 MG 24-HOUR TABLET, 1 TABLET BY MO.; MULTIVITAMIN TABLETS, 1 TABLET BY MOUTH ONCE DAILY.; NITROGLYCERIN 0.4 MG SL, DISSOLVE 0.4 MG UNDER TON.; OMEGA-3 FATTY ACIDS 340-1000 MG CAPSULES, 1 CAPSUL.; OMEPRAZOLE 20 MG DELAYED RELEASE CAPSULE, 1 CAPSUL.; TICAGRELOR 90MG TABLETS, 1 TABLET BY MOUTH ONCE DA.; TRAZODONE 100 MG TABLETS, 1 TABLET BY MOUTH ONCE D.
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American