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

Model Number VACDSP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Hemorrhage/Bleeding (1888); Pressure Sores (2326)

Event Date 05/04/2021

Event Type  Injury  

Manufacturer Narrative

The specific date was not provided.Kci was notified of the event on (b)(6) 2021; therefore, this is the date utilized.The device identifier was not provided and the product was not returned for evaluation; therefore, a device evaluation could not be performed.Based on the information provided, it cannot be determined when the v.A.C.® dressing was placed or how long the patient was laying on the tubing clamp.Kci has made multiple unsuccessful attempts to obtain additional clinical and device information.The bleeding noted was considered minor with no allegation, indication or evidence that medical or surgical intervention was required to resolve the bleeding.A device history record review and a device evaluation was unable to be performed as the v.A.C.® dressing identifier was not provided and the product was not returned.The patient has a spinal cord injury and is paraplegic; therefore, the patient was unable to identify the location of the tubing clamp.This is indicative of the improper placement of the tubing based on the patient's etiology.This event is being reported as a potential use error.Device labeling, available in print and online, states: clinical considerations: care must be taken to prevent trauma and/or pressure when placing v.A.C.® tubing, particularly over bony prominences.Protect periwound skin: if any signs of irritation or sensitivity to the drape, foam or tubing assembly appear, discontinue use and consult a physician.Extra caution should be used for patients with neuropathic etiologies or circulatory compromise.Maintaining a seal: position the dressing tubing on flat surfaces and away from the perineal area, bony prominences or pressure areas.Secure or anchor the tubing with an additional piece of drape or tape, positioning the anchor several centimeters away from the dressing or wound.This prevents tension on the tubing from pulling on the dressing.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.

Event Description

On (b)(6) 2021, the following information was provided to kci by the patient: the clamp / white connector on the v.A.C.® dressing tubing allegedly caused a pressure injury to the patient's right leg that was reportedly bleeding.The wound allegedly required debridement.The patient was subsequently placed on a wet to dry dressing regimen and noted the stage of the right leg wound has not been determined.The patient has a spinal cord injury and was not aware of the injury until the home health agency presented for a dressing change.The patient continues to utilize v.A.C.® therapy.No additional clinical information was provided.The v.A.C.® dressing identifier was not provided, and the product was not returned; therefore, a device history review and a device evaluation could not be performed.

Manufacturer Narrative

Mdr-3009897021-2021-00117 submitted on 03-jun-2021 noted the following: d2 common device name: nad, product code: nad.Correction d2 type of device: omp, product code: omp.Based on the correction provided, kci's assessment remains the same; it cannot be determined when the v.A.C.® dressing was placed or how long the patient was laying on the tubing clamp.

• Brand Name: V.A.C. DRESSING
• Type of Device: OMP
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX 78249
• MDR Report Key: 11934968
• MDR Text Key: 266873961
• Report Number: 3009897021-2021-00117
• Device Sequence Number: 1
• Product Code: OMP
• Combination Product (y/n): N
• PMA/PMN Number: K133276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• 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: 05/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR