MAUDE Adverse Event Report: REYNOSAL MANUFACTURING LIBERTY CYCLER SET, SINGLE CONN./EXT. DL; PERITONEAL DIALYSIS TUBING SET, FKX

Model Number LIBERTY CYCLER SET

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 04/25/2010

Event Type  Death  

Event Description

Patient's daughter reported to the fda on (b)(6) 2011 three product numbers.The patient received this product number.No lot number is available.During follow up it was learned the patient had died.

Manufacturer Narrative

A product investigation was performed for this device.The actual device was not returned for evaluation.A review of the device history record was performed.There were no unexpected variances, adjustments or comments noted in the device record.A review was performed by the post market clinical department.Per the pharmacovigilance associate medical director, it is unlikely that the pd products were causally related to the patient's death.The patient had severe aortic stenosis, hypotension, with negative peritoneal cultures.The products in question were subject to recall because of an increased incidence of leaks developing during treatment.The fluid path of these products is sterile in the absence of a leak.The information available does not mention the presence or occurence of fluid leaks and the patient was reported to have had negative peritoneal dialysate cultures.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 (b)(6) 2011 to (b)(6) 2013.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Type of Device: PERITONEAL DIALYSIS TUBING SET, FKX
• Manufacturer (Section D): REYNOSAL MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps 8879 0; MX 88790
• Manufacturer Contact: tanya taft ; 920 winter street; waltham, MA 02451 ; 7816999751
• MDR Report Key: 4129305
• MDR Text Key: 18543684
• Report Number: 8030665-2014-00726
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Type of Report: Initial
• Report Date: 05/17/2011

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 CYCLER SET
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2011
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 85 YR