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

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 10/01/2013

Event Type  Death  

Event Description

A nurse reported that a pt expired on an unk date in (b)(6) 2013.This nurse reported that the pt was not dialyzing at the time of death.There were no allegation against any fresenius product in relation to the reported event.Limited info was provided for this safety report.

Manufacturer Narrative

Based on the info provided, it is unk how the device may have caused or contributed to the event.The post market surveillance department has requested medical records and investigations are pending.A supplemental medwatch report will be submitted when medical records are received.The device was not returned to the manufacturer for analysis.The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4229737
• MDR Text Key: 4998269
• Report Number: 2937457-2014-03040
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2010
• 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
• Treatment: LIBERTY CYCLER CASSETTE; DELFLEX PD SOLUTION
• Patient Outcome(s): Death