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

Model Number LIB

Device Problem Device Inoperable (1663)

Patient Problem Peritonitis (2252)

Event Date 10/05/2011

Event Type  Injury  

Event Description

Patient performing peritoneal dialysis from home called tech support because the cycler screen went blank during set up.Patient stated that this was his first treatment after hospitalization.Per clinic nurse cycler was replaced and patient continues on (ccpd) continous cycling peritoneal dialysis.While gathering information on the hospitalization the patient nurse disclosed that the patient had been diagnosed with peritonitis in september of that year.

Manufacturer Narrative

The cycler was returned with no evidence of dried fluid residue.The blank display problem was duplicated when turning on the cycler.Replacement of the inverter board repaired the display failure.Cycler passed all testing after inverter board replacement.Per the fresenius clinical investigation: there is no contact between dialysis solution and cycler which would cause an infection.There was no report of a fluid leak.There were no reported problems with the cycler just prior to the peritonitis event.Most common cause of peritonitis is touch contamination.The peritonitis event predated the tech support call.The hospitalization event was due to catheter problems.Per patient's nurse, the patient continues on continuous cycling peritoneal dialysis using the liberty cycler.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 (b)(4) 2011 to (b)(4) 2013.

• Brand Name: FRESENIUS LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 84520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4060110
• MDR Text Key: 4731494
• Report Number: 2937457-2014-01987
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2011
• 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): Other
• Patient Age: 54 YR