MAUDE Adverse Event Report: CAREFUSION 2200, INC. PLEURX DRAINAGE KIT; PERITONEAL, DRAINAGE CATHETER

Model Number 50-7510 1000ML

Device Problems Tidal Volume Fluctuations (1634); Defective Device (2588); Improper Flow or Infusion (2954); No Pressure (2994)

Patient Problem Dyspnea (1816)

Event Date 05/29/2018

Event Type  Injury  

Event Description

My father-in-law lives in our home and my husband and i are his primary caregivers.He has pleural effusion and the cause is unknown to doctors.We currently provide daily care, draining fluid from around his lungs using a pleurx drainage kit with a 1000 ml vacuum bottle.His average drainage volume has been 750 - 1000 ml per day.Over the past few weeks, we've noticed days when there were lower volumes, but when we went to empty the bottle, there was no pressure remaining in the bottle.Two days ago, the bottle stopped flowing at 500 ml.I checked the bottle and there was no pressure remaining.Because my father-in-law was short of breath, i opened another bottle and drained another 350 ml.Today, the bottle stopped at 750 ml and there was no pressure remaining.I couldn't use another bottle because we would run out before another supply was delivered, but he was still short of breath.We are only sent 10 bottles at a time and have zero extra supplies.(b)(6) medical supplies also will only ship on the day before you are about to run out of supplies - they say because of medicare rules.This recent pattern is very concerning.My father-in-law is not in good health.Defective bottles that are not adequately pressurized to remove the fluid from around his lungs could endanger his life.At the same time, we are much more fortunate than most people.I'm home with my father-in-law during the day and my husband is a physician.We figured out that the low volumes were because the bottles were defective.Other individuals or families may not be so fortunate! carefusion/pleurx also changed the foam material they use as the barrier between the skin and the adhesive.It feels/looks like lower density/quality foam.I highly doubt that savings were passed along to medicare or patients.My husband reported the defective bottles to (b)(6) medical today.

• Brand Name: PLEURX DRAINAGE KIT
• Type of Device: PERITONEAL, DRAINAGE CATHETER
• Manufacturer (Section D): CAREFUSION 2200, INC.
• MDR Report Key: 7556592
• MDR Text Key: 109896156
• Report Number: MW5077552
• Device Sequence Number: 1
• Product Code: PNG
• UDI-Device Identifier: 10885403090707
• UDI-Public: (01)10885403090707
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 05/29/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/25/2020
• Device Model Number: 50-7510 1000ML
• Device Catalogue Number: DB507510EP
• Device Lot Number: 0001219858
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 93