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

Model Number LIB

Device Problem Filling Problem (1233)

Patient Problem Injury (2348)

Event Date 01/03/2012

Event Type  Injury  

Event Description

A home peritoneal dialysis patient called technical support because of pain during continuous cycling peritoneal dialysis.The patient was assisted in disconnecting from the cycler and patient was advised to call her peritoneal dialysis nurse.Seven days later, patient in the hospital with peritonitis.

Manufacturer Narrative

The product was not returned for evaluation.The event peritonitis is unlikely related to the liberty cycler machine.There is no evidence of product malfunction or any fluid leaks.Medical records and treatment sheets were not available for review.This is a retrospective mdr being submitted by fresenius medical care as a remediation action committed to fda regarding complaints of deaths or serious injuries received between 21 march 2011 to 11 march 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 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4060081
• MDR Text Key: 4730966
• Report Number: 2937457-2014-01996
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: RTLR180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2012
• Initial Date FDA Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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