MAUDE Adverse Event Report: KINETIC CONCEPTS, INC. SNAP 125MMHG THERAPY CARTRIDGE; OKO

Model Number WNDSNP

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

Patient Problem Tissue Breakdown (2681)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

Device discarded, identifier not known.Based on information provided, it cannot be determined that the alleged graft failure is related to the snap¿ therapy system.Device labeling, available in print and online, states: warnings never leave the snap¿ therapy dressing in place without active negative pressure therapy unless under clinical supervision.If the red pressure discharge indicator becomes visible, negative pressure is no longer active.Physician instructions: the physician instructions to the clinician/caregiver should contain: negative pressure level to be used, dressing change frequency, adjunctive dressings to be used, patient training and guidance, desired treatment duration and/or end-point.Ensure the patient and/or caregiver understands the following before release: frequency of snap¿ therapy cartridge inspection (at a minimum every eight hours).Troubleshooting: problem: airtight seal is not present at wound dressing and red pressure discharge indicator is visible or green capacity indicator does not remain stationary in chamber window.Possible solution: check that tubing connections are secure.Smooth dressing with fingers to flatten wrinkles.Seal dressing edges with additional 3m¿ tegaderm¿ dressing.Apply snap¿ securing¿ hydrocolloid to dressing edge to seal difficult anatomical locations.Problem: airtight seal is not present at wound and green capacity indicator is stationary.Possible solution: examine tubing for possible occlusion or kinks.If found, straighten tubing or replace snap¿ therapy dressing.Occlusion may reside in wound dressing.Replace wound dressing.

Event Description

On 08-apr-2019, the following information was reported to kci by the physician: the patient's wound was located on the posterior aspect of the right ankle and measured 3cm x 3cm.The patient underwent a graft placement, and the snap¿ therapy system was applied.The patient experienced a technical issue with the snap¿ therapy system and allegedly spent the night without pressure to the dressing.The following morning, the kci consultant and the physician reportedly tried several "maneuvers to make the dressing work" with no success.The physician opted to replace the entire dressing with a second snap¿ therapy system, but allegedly experienced the same technical issue.The physician decided to remove the second snap¿ therapy system and apply v.A.C.® therapy system in order to guarantee a successful graft outcome.On 08-jul-2019, the following information was reported to kci by the physician: one hundred percent of the graft failed allegedly due to the snap¿ therapy system not providing pressure.The patient underwent a debridement with a new graft placement and activac¿ therapy.A device history review of lot number 5362894 determined there were no nonconformances identified or deviations used during the manufacture of this lot.All end release testing of product and packaging met specifications.

• Brand Name: SNAP 125MMHG THERAPY CARTRIDGE
• Type of Device: OKO
• Manufacturer (Section D): KINETIC CONCEPTS, INC.; san antonio TX
• Manufacturer Contact: steven jackson ; 6203 farinon drive; san antonio, TX 78249 ; 2102556438
• MDR Report Key: 8878247
• MDR Text Key: 154585215
• Report Number: 3009897021-2019-00112
• Device Sequence Number: 1
• Product Code: OKO
• UDI-Device Identifier: 00849554005501
• UDI-Public: 010084955400550117200731105362894
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K132080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2019

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 Expiration Date: 07/31/2020
• Device Model Number: WNDSNP
• Device Lot Number: 5362894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention