MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR; ELASTOMERIC - SAF

Model Number CB004

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

Patient Problems Unspecified Infection (1930); Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 26-jun-2018 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).

Event Description

Fill volume: 550 ml, flow rate: unknown, procedure: total knee arthroplasty, cathplace: adductor canal.It was reported that a patient experienced an infection associated with the use of an elastomeric pump and braun catheter.The patient had a total knee arthroplasty (tka) about six weeks ago and developed necrotic where the catheter insertion site was located.The catheter and pump were removed and discontinued around pod 2 before the patient was discharged.Prior to discharge, a small blister was noted near the catheter insertion site.Several days later, the blister became worse and it was confirmed that the patient developed necrotic tissue.It was believed that the necrosis was due to the catheter being coiled up and causing a tourniquet like application to the skin.The infection became so bad, it was noted, that it traveled down to the knee joint.Six weeks after the initial surgery, a wound debridement and a knee joint revision were performed on (b)(6) 2018.It was unknown if antibiotics were administered.However, at this time, the patient is doing well.

• Brand Name: ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW, 400 ML, 2-14 ML/HR
• Type of Device: ELASTOMERIC - SAF
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 7645702
• MDR Text Key: 112583121
• Report Number: 2026095-2018-00071
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 30680651134722
• UDI-Public: 30680651134722
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CB004
• Device Catalogue Number: 101347200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 0.2 % ROPIVAVAINE; BRAUN CATHETER
• Patient Outcome(s): Other; Required Intervention