MAUDE Adverse Event Report: FRESENIUS MED CARE NORTH AMERICA, REYNOSA MFG LIBERTY CYCLER SET, DUAL PT CONNECT

Catalog Number 050-87212

Device Problems Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 09/26/2014

Event Type  malfunction  

Event Description

A peritoneal dialysis pt reported that dialysis solution leaked out of the cassette and into the cycler.When breaking down the cycler, pt found a fluid leak inside cassette door.Pt stated that the cassette had a tear in the back.Pt's effluent has remained clear.He had no adverse effects and did not require any med intervention.Sample is not available.Sample was discarded.

Manufacturer Narrative

The device was not returned to the mfr for physical eval and the lot number was not able to be obtained to date.Distribution records were reviewed to identify potential lots of this product shipped to the customer within the past three months.An alternate sample from one of the lots from the distribution ctr was returned for investigation and no defects were noted.In addition, an investigation of the device mfg records was conducted by the mfr.There were no deviations or nonconformities during the mfg process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: LIBERTY CYCLER SET, DUAL PT CONNECT
• Manufacturer (Section D): FRESENIUS MED CARE NORTH AMERICA, REYNOSA MFG; cd, reynosa, tamps ; MX
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st; waltham, MA 02451 ; 8006621237
• MDR Report Key: 4230816
• MDR Text Key: 4976921
• Report Number: 8030665-2014-00829
• 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,Company Representative
• Type of Report: Initial
• Report Date: 09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87212
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/26/2014
• 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
• Treatment: LIBERTY DIALYSIS CYCLER; PD SOLUTIONS
• Patient Age: 52 YR