MAUDE Adverse Event Report: REYNOSA MFG LIBERTY CYCLER SET, DUAL PT CONNECT; LIBERTY DIALYSIS CYCLER TUBING

Model Number N/A

Device Problem Partial Blockage (1065)

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

Event Date 07/30/2012

Event Type  malfunction  

Event Description

A peritoneal dialysis pt has reported inability to fill after getting a pt line is blocked alarm on his ccpd cycler.Pt presented to his dialysis clinic where pd nurse changed the extension set and noticed the blue pin had broken off and was stuck in the extension set.Once changed, the pt experienced no further problems; patency of the catheter and extension set was re-established.Pt states no ill effects noticed or antibiotics taken.He states cultures were drawn with negative results.Effluent has remained clear.There is no sample available for eval.

Manufacturer Narrative

A medical review was performed on the available info and the cause of the event is undetermined.No add'l pertinent info noted.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 21 march 2011 to 11 march 2013.

• Brand Name: LIBERTY CYCLER SET, DUAL PT CONNECT
• Type of Device: LIBERTY DIALYSIS CYCLER TUBING
• Manufacturer (Section D): REYNOSA MFG; reynosa ; MX
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999751
• MDR Report Key: 4070941
• MDR Text Key: 4894329
• Report Number: 8030665-2014-00697
• 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,Health Professional,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/30/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2015
• Device Model Number: N/A
• Device Catalogue Number: 050-87212
• Device Lot Number: 12DR08001
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/30/2012
• Initial Date FDA Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2012
• 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
• Patient Age: 78 YR
• Patient Weight: 104