PLEURX DRAINAGE KIT 50-7510 1000ML DB507510EP

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-30 for PLEURX DRAINAGE KIT 50-7510 1000ML DB507510EP manufactured by Carefusion 2200, Inc..

Event Text Entries

[109896156] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077552
MDR Report Key7556592
Date Received2018-05-30
Date of Report2018-05-29
Date of Event2018-05-29
Date Added to Maude2018-05-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NamePLEURX DRAINAGE KIT
Generic NamePERITONEAL, DRAINAGE CATHETER
Product CodePNG
Date Received2018-05-30
Model Number50-7510 1000ML
Catalog NumberDB507510EP
Lot Number0001219858
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION 2200, INC.

Device Sequence Number: 2

Brand NamePLEURX DRAINAGE KIT
Generic NamePERITONEAL, DRAINAGE CATHETER
Product CodePNG
Date Received2018-05-30
Model Number50-7510 1000ML
Catalog NumberDB507510EP
Lot Number0001219858
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerCAREFUSION 2200 INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2018-05-30

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