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

Model Number WNDULT

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

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

Based on information provided, it cannot be determined that the alleged hemorrhage was related to the v.A.C.Ulta¿ negative pressure wound therapy system.The patient was on three anticoagulant medications, and thus, was prone to bleeding.Kci has not been able to obtain sufficient information to establish a root cause.Device labeling, available in print and online, states: warnings 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, 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.

Event Description

On (b)(6) 2019, the following information was reported to kci by the nurse: on (b)(6) 2019, the nurse allegedly observed frank blood in the v.A.C.® therapy canister.Upon v.A.C.Ulta¿ negative pressure wound therapy system removal, the wound was allegedly actively bleeding and pressure was applied.The patient went to the emergency room where the wound was sutured in order to achieve hemostasis.On (b)(6) 2019, kci received the following information: per physician note dated (b)(6) 2019, there is "brisk bleeding from a small muscular arterial branch on the sartorius flap.The physician placed a stich and no further bleeding was observed afterward wound vac may be reapplied tomorrow." the nurse noted that the patient reportedly climbed over the bed rail to get into bed, and frank blood was subsequently observed in the tubing.V.A.C.Ulta¿ therapy was removed, and direct pressure was applied from 0945 to 1130 hours.It was also noted that v.A.C.Ulta¿ therapy may have contributed to the adverse event.The event occurred after the patient climbed over the bed rail and the nurse alleged that the continuous pressure of v.A.C.Ulta¿ therapy on a weakened vessel possibly ripped open the suture.The patient required a suture of a small artery as well as a blood transfusion.The amount was not provided.The event resolved after three hours and the patient is reportedly stable.A device evaluation of the v.A.C.Ulta¿ negative pressure wound therapy system is currently pending completion.

Manufacturer Narrative

Other (code unspecified, describe in h10): device not returned.Based on the information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged hemorrhage was related to the v.A.C.Ulta¿ negative pressure wound therapy system.

Event Description

On 12-aug-2019, 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) 2019, the device was placed with the patient.To date, the facility is unable to locate the device and it has not been returned to kci; therefore, kci quality engineering is not able to perform an evaluation of the device.

Event Description

On 31-mar-2020, a device evaluation was completed by quality engineering.On 25-mar-2020, the device was tested per quality control procedure by kci quality engineering 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 information provided regarding the device, kci's assessment remains the same; it cannot be determined that the alleged hemorrhage was related to the v.A.C.Ulta¿ negative pressure wound therapy system.The device met quality control specifications before and after patient placement.

• Brand Name: V.A.C.ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• MDR Report Key: 9119190
• MDR Text Key: 163338869
• Report Number: 3009897021-2019-00195
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554001244
• UDI-Public: 0100849554001244
• Combination Product (y/n): N
• PMA/PMN Number: K100657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WNDULT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN 81 MG DAILY; LOVENOX 40 MG DAILY; PLAVIX 75 MG DAILY; RIFAMPIN 300 MG (FREQUENCY NOT PROVIDED)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 77