MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

Catalog Number 050-87216

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 device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed.The entire lot has been sold and distributed.However, 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 reported finding a fluid leak following his treatment.While removing the cassette he found moisture inside the cassette door.The patient 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.The patient had not experienced any complications due to the event.He was not prescribed any antibiotics.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Manufacturer (Section D): FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; erika de reynosa, s.a. de c.v.; mike allen 1331 parque industrial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5346835
• MDR Text Key: 35971175
• Report Number: 8030665-2015-00617
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/30/2015

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: 07/01/2018
• Device Catalogue Number: 050-87216
• Device Lot Number: 15JR08204
• Other Device ID Number: 00840861100750
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/30/2015
• 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: 48 YR
• Patient Weight: 73