MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C.ULTA¿ THERAPY SYSTEM; OMP

Model Number WNDULT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Exsanguination (1841)

Event Date 07/23/2022

Event Type  Death  

Manufacturer Narrative

Based on the information provided, it cannot be determined that the patient's death was related to the v.A.C.Ulta¿ therapy system.The patient had a history of post operative complications and was on anticoagulant therapy.The device passed quality control checks before and after patient placement.Device labeling, available in print and online, states: v.A.C.Ulta¿ therapy system contraindications ·do not place foam dressings of the v.A.C.Ulta¿ therapy system (including both v.A.C.® therapy and v.A.C.Veraflo¿ therapy dressings) directly in contact with exposed blood vessels, anastomic sites, organs, or nerves.V.A.C.Ulta¿ therapy system warnings bleeding: with or without using v.A.C.® therapy or v.A.C.Veraflo¿ 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 or v.A.C.Veraflo¿ 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 v.A.C.Veraflo¿ therapy, or if frank (bright red) blood is seen in the tubing or in the canister, immediately stop therapy, leave dressing in place, take measures to stop the bleeding and seek immediate medical assistance.The v.A.C.Ulta¿ therapy unit and dressings (both v.A.C.® therapy or v.A.C.Veraflo¿ therapy) 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 or v.A.C.Veraflo¿ therapy.Always ensure that v.A.C.® foam dressings and v.A.C.Veraflo¿ 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, bio-engineered tissue or 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.Consideration should also be given to the negative pressure setting and therapy mode when used when initiating therapy.Caution should be taken when treating large wounds that may contain hidden vessels which may not be readily apparent.The patient should be closely monitored for bleeding in a care setting deemed appropriate by the treating physician.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 26-jul-2022, the following information was provided by a hospital employee: it was believed the v.A.C.Ulta¿ therapy system was being utilized on a patient's heart.The v.A.C.Ulta¿ therapy system was removed in the operating room and the "heart exploded".On 29-jul-2022, the following information was provided by the clinical coordinator: the patient's heart did not "explode".An alarm was noted on the v.A.C.Ulta¿ therapy system prior to the event.There was an attempt to remove the dressing at the bedside and bleeding was noted.The patient was taken into the operating room and an active bleed was noted when the dressing was removed.On 12-aug-2022: the following information was provided by the physician: the patient underwent debridement and placement of v.A.C.Whitefoam¿ dressing and the v.A.C.Ulta¿ therapy system to the mediastinum.The v.A.C.Ulta¿ therapy system alarmed for an obstruction while utilizing veraflo¿ therapy prior to the event.The patient required femoral cardiopulmonary bypass, repair of the right ventricle, blood transfusion and intubation but expired.V.A.C.® therapy may have contributed to the adverse event as the pathology showed necrosis and no bacterial/neutrophil invasion.On 15-aug-2022, a device evaluation was completed by kci quality engineering.On 18-jul-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 19-jul-2022, the device was placed with the patient.On 01-aug-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.Inspection and testing of the device did not reveal any evidence of an operational malfunction with the unit.

• Brand Name: V.A.C.ULTA¿ THERAPY 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: 15275329
• MDR Text Key: 298395565
• Report Number: 3009897021-2022-00137
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554001244
• UDI-Public: 0100849554001244
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162790
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDULT
• Device Catalogue Number: 350000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• 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: AMIODARONE 400MG BID; DAPTOMYCIN 500MG IVPB QD; FLOMAX 0.4MG QD; GABAPENTIN 600MG BID; IRON 325MG QD; LIPITOR 40MG QD; LOVAZA 2G BID; LOVENOX 40MG QD; METOPROLOL 50MG QD; OXYCODONE 10MG ONCE; PEPCID 20MG BID; TYLENOL 650MG Q6H; VITAMIN C 500MG BID
• Patient Outcome(s): Death
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 114 KG