MAUDE Adverse Event Report: REYNOSA MANUFACTURING LIBERTY CYCLER SET, DUAL PATIENT CONNECT

Catalog Number 050-87212

Device Problems Fluid/Blood Leak (1250); Scratched Material (3020)

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

Event Date 02/19/2014

Event Type  malfunction  

Event Description

A peritoneal dialysis patient has reported that dialysis solution was leaking out of the cassette and into the cycler.When removing the cassette, fluid began to leak.Prophylactic antibiotics were administered as a precaution and there is no other known patient ill effects.Sample is available.

Manufacturer Narrative

The actual device was returned to the manufacturer for physical evaluation and the complaint is confirmed with a scratch on the film of the cassette.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material and process controls were within specification.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• Manufacturer (Section D): REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; mike allen 1331; parque industrial reynosa; reynosa, tamaulipas CP 8 8780; MX CP 88780
• Manufacturer Contact: jennifer nabukenya ; 920 winter street; waltham, MA 02451 ; 8006221237
• MDR Report Key: 3847647
• MDR Text Key: 4683991
• Report Number: 8030665-2014-00232
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K0433633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: 050-87212
• Device Lot Number: 13PR08039
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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