MAUDE Adverse Event Report: TELEFLEX MEDICAL PLEUR-EVAC; APPARATUS, AUTOTRANSFUSION

Catalog Number A-8000-08LF

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem Pleural Effusion (2010)

Event Date 11/17/2015

Event Type  malfunction  

Event Description

A middle-aged person with history of cerebral palsy and seizure disorder was admitted with large left pleural effusion.Pt had successful placement of a 12 french chest tube placed under ct guidance in radiology and pt was transferred to critical care.Following transfer to critical care unit, respiratory therapist noted there was too much fluid in the under water seal column and 20 cc was removed from the under water seal column.Shortly thereafter, the fluid had increased in the under water seal column again.It was noted the color of the water was not the typical blue color but was greenish yellow and appeared to be drainage from the patient.A new pleuro vac system was replaced to the chest tube and appeared to be working appropriately.Internal investigation revealed the chest tube was attached to the water seal chamber instead of the collection chamber.Thus, it appeared to be user error.Staff education of proper procedure for connection the pleurovac to the chest tube and wall suction was completed.Unfortunately the original pleuro vac container was not saved.Respiratory therapy supervisor is in the process of evaluating and requesting a newer, dry/wet unit that is less complicated, similar cost and easier to set up.Manufacturer response for under water suction canister, pleur-evac (per site reporter): i have contacted teleflex customer service via email to report equipment failure.There is no telephone access based on website.Reply received and will contact me within 24 hours.

• Brand Name: PLEUR-EVAC
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): TELEFLEX MEDICAL; 2917 weck drive; research triangle park NC 27709
• MDR Report Key: 5305465
• MDR Text Key: 33719851
• Report Number: 5305465
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2015

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: No Information
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: A-8000-08LF
• Device Lot Number: 74E1502639
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/30/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/30/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CHEST TUBE
• Patient Age: 31 YR
• Patient Weight: 37