MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER

Model Number LIB

Device Problem Occlusion Within Device (1423)

Patient Problems Abdominal Pain (1685); Constipation (3274)

Event Date 03/04/2012

Event Type  Injury  

Event Description

The peritoneal dialysis (pd) patient reported "patient line blocked" alarm in fill 1 of pd treatment of the liberty cycler on (b)(6) 2012.The patient stated that the patient line looked fine, but she was experiencing stomach pain.The patient stated her drain location on her abdomen was dark and cloudy, and she felt a throbbing pain.The patient ended pd treatment and was referred to her pd nurse.The patient reported on (b)(6) 2012, that she was still having pain and not having successful treatments for the last 3 days.Per the pd nurse, the patient was unable to drain manually and her abdomen was big and tight.The patient was subsequently hospitalized.The nurse added heparin and vancomycin to the patient's solution bags.

Manufacturer Narrative

A clinical investigation was performed.During a follow-up call with the patient, she stated her inability to drain was due to scar tissue blocking the drain flow.The patient's catheter was changed.Per the fmc associate medical director, inability to drain during ccpd (continuous cycler peritoneal dialysis) resulting in abdominal pain, tightness, and enlargement is unlikely related to the liberty cycler.There were no reports of any machine malfunction.Drainage problems were due to presence of adhesions and scar tissues, which were blocking the flow of pd fluid.The patient was hospitalized and the pd catheter was replaced.Currently, the patient is on ccpd using the same cycler without any problems reported.Medical history and discharged summary from hospitalization were not available for review.The actual device was returned to the manufacturer for evaluation and a product investigation was performed.A visual inspection was performed and the deice was in good condition.A system air leak test and valve actuation test was performed and failed specifications.The air compressor was replaced and the device passed both tests.A simulated treatment was completed without any alarms or noted problems.The device was determined to be functioning according to product specifications.Further evaluation found no device malfunctions that would have caused the reported abdominal pain.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 march 21, 2011 to march 11, 2013.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA, WALNUT CREEK PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4083450
• MDR Text Key: 4825759
• Report Number: 2937457-2014-02165
• 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: Other,Consumer
• Type of Report: Initial
• Report Date: 03/04/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIB
• Device Catalogue Number: 180020
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/04/2012
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 23 YR
• Patient Weight: 51