MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. V.A.C.® DRESSING; OMP

Model Number VACDSP

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

Patient Problems Hemorrhage/Bleeding (1888); Rupture (2208)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

Additional device information: the v.A.C.® dressing lot number and udi number are unknown as the dressing was discarded.The activ.A.C.¿ ion progress¿ remote therapy monitoring serial and udi numbers were provided.Based on information provided, it cannot be determined that the alleged venous rupture is related to the v.A.C.® dressing.The patient was on anticoagulant medications, and thus, was prone to bleeding and would experience difficulty arresting a hemorrhage.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 provided to kci by the nurse: the patient allegedly experienced a venous rupture.On (b)(6) 2019, the following information was provided to kci by the nurse: the patient experienced a small venous rupture post dressing change that required 1 or 2 sutures.The nurse noted the venous rupture was most likely due to the v.A.C.® dressing removal, and no blood transfusion was required.The v.A.C.® dressing lot number was unknown as the dressing was discarded.The v.A.C.® dressing type and lot number were not available, therefore a device history review could not be performed.A device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring is currently pending completion.

Event Description

The nurse noted the venous rupture was most likely due to the v.A.C.® dressing removal.The v.A.C.® dressing type and lot number were not available, therefore a device history review could not be performed.

Manufacturer Narrative

Mdr-3009897021-2019-00109 section b5, sent on (b)(6) 2019 noted the following: a device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring is currently pending completion.Correction: a device evaluation of the activ.A.C.¿ ion progress¿ remote therapy monitoring is not required as the nurse noted the venous rupture was most likely due to the v.A.C.® dressing removal.The v.A.C.® dressing type and lot number were not available, therefore a device history review could not be performed.Based on the corrected information, kci's assessment remains the same; it cannot be determined that the alleged venous rupture is related to the v.A.C.® dressing.

• Brand Name: V.A.C.® DRESSING
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• MDR Report Key: 8878769
• MDR Text Key: 153849822
• Report Number: 3009897021-2019-00109
• Device Sequence Number: 1
• Product Code: OMP
• UDI-Device Identifier: 00849554005600
• UDI-Public: 0100849554005600
• Combination Product (y/n): N
• PMA/PMN Number: K063692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VACDSP
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALDACTONE 12.5 MG EVERY OTHER DAY; ASPIRIN 81 MG DAILY; BACTRIM DS 160 MG DAILY; BUMEX 2 MG DAILY; CLEOCIN 300 MG THREE TIMES A DAY; ELIQUIS 2.5 MG 2 TIMES A DAY; KEFLEX 500 MG 2 TIMES A DAY; NITROSTAT 0.4 MG EVERY 5 MINUTES PRN; VALIUM 5 MG 2 TIMES A DAY; ALDACTONE 12.5 MG EVERY OTHER DAY; ASPIRIN 81 MG DAILY; BACTRIM DS 160 MG DAILY; BUMEX 2 MG DAILY; CLEOCIN 300 MG THREE TIMES A DAY; ELIQUIS 2.5 MG 2 TIMES A DAY; KEFLEX 500 MG 2 TIMES A DAY; NITROSTAT 0.4 MG EVERY 5 MINUTES PRN; VALIUM 5 MG 2 TIMES A DAY
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 83