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

Catalog Number 050-87212

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/02/2015

Event Type  malfunction  

Manufacturer Narrative

The actual device was not returned to the manufacturer for physical evaluation, however, a companion sample from the same lot was returned from stock for investigation and n o defects were noted during visual evaluation and simulated use testing.In addition, 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.

Event Description

A peritoneal dialysis (pd) patient's contact reported the cycler alarmed for air detected in the cassette during fill 3 of 4.The treatment was discontinued.When the cassette door was opened fluid was found to be leaking.The contact was advised to contact the pd nurse.The set was discarded.During follow up the patient's pd nurse reported the patient had clear effluent and no signs of an infection.She was not prescribed any antibiotics.

• Brand Name: LIBERTY CYCLER SET, DUAL PATIENT CONNECT
• Manufacturer (Section D): FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps ; MX
• Manufacturer Contact: brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps
• MDR Report Key: 5346832
• MDR Text Key: 35971225
• Report Number: 8030665-2015-00615
• Device Sequence Number: 1
• Product Code: FKX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/01/2018
• Device Catalogue Number: 050-87212
• Device Lot Number: 15JR08066
• Other Device ID Number: 00840861100736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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 Age: 60 YR
• Patient Weight: 79