MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MANUFACTURING PLIBERTY CYCLER SET, DUAL PATIENT CONNECT

Catalog Number 050-87212

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2015

Event Type  malfunction  

Event Description

A peritoneal dialysis home therapy coord reported that dialysis solution leaked out of the tubing set.The coord stated that while the pt was connected to pd liberty cycler receiving her ccpd treatment, she woke up feeling wetness on her bed and noticed that the line was separated from the bottom part of the connector.Pt was administered prophylactic antibiotics and her drainage remained clear.Sample has not been returned to the manufacturer.

Manufacturer Narrative

The plant investigation has not yet been completed.A f/u report will be filed upon completion of the investigation.

• Brand Name: PLIBERTY CYCLER SET, DUAL PATIENT CONNECT
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA, REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4780574
• MDR Text Key: 20755324
• Report Number: 8030665-2015-00249
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: 050-87212
• Device Lot Number: 14NR08037
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• 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
• Treatment: LIBERTY DIALYSIS CYCLER; PD SOLUTIONS