MAUDE Adverse Event Report: REYNOSA MANUFACTURING LIBERTY DRAIN SET W/4-5 LITER BAGS; PERITONEAL DIALYSIS DRAIN SET

Model Number LIBERTY DRAIN SET

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Date 11/10/2011

Event Type  Injury  

Event Description

A peritoneal dialysis pt called fresenius technical support regarding a drain line blocked message during drain 1.The pt drained 290/2317 ml and when pressing "ok" he drains a ml per minute.Tech support had the pt check the pt line and drain lines for air, fibrin, kinks, pin pushed in and made sure the end of the line was ok.Tech support had the pt reposition himself, but the pt was still draining slowly.The pt mentioned he had called his nurse about this since it had been happening for a few days now, and she told him to replace his cycler.The pt also stated he had just gotten out of the hosp for peritonitis.Tech support replaced the cycler, the pt will resort to alternate treatments for tonight.

Manufacturer Narrative

A product investigation was performed for this device.The actual device was not returned for eval.A review was performed by the post market clinical department.On (b)(6) 2011, the pt presented to the hosp with complaints of abdominal pain and cloudy affluent.He was admitted on the same day with a diagnosis of peritonitis and treated with vancomycin and fortaz ip and discharged on (b)(6) 2011.On (b)(6) 2011, the pt reported that his drain line was blocked during drain 1.He drained 290/2317 ml and when pressing ok he drains 1 ml per minute.Pt then continued with alternate treatment for that night.It has since been learned that the pt died on (b)(6) 2012, cause of death is listed as cardiac arrest.Per the pharmacovigilance physician, the pt's death was temporally related to the complaint of a blocked drain line.The pt's peritonitis preceded the complaint of blocked drain line and therefore, the blocked drain line could not have caused or contributed to the pt's hospitalization and treatment for peritonitis.Peritonitis is typically due to touch contamination of the pd catheter/tubing connection and there were no reported fluid leaks.This is a retrospective mdr being submitted by fresenius medical care as a remediation action committed to fda regarding all potential adverse events received between 03/21/2011 to 03/11/2013.

• Brand Name: LIBERTY DRAIN SET W/4-5 LITER BAGS
• Type of Device: PERITONEAL DIALYSIS DRAIN SET
• Manufacturer (Section D): REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA; brecha e99; parque industrial reynos, bldg. ii; cd, reynosa, tamps 8879 0; MX 88790
• Manufacturer Contact: tanya taft ; 920 winter st; waltham, MA 02451 ; 7816999751
• MDR Report Key: 4112638
• MDR Text Key: 4918981
• Report Number: 8030665-2014-00725
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K811986
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 11/10/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY DRAIN SET
• Device Catalogue Number: 026-20226
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/10/2011
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR
• Patient Weight: 91