MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE LIBERTY CYCLER

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 08/04/2014

Event Type  Death  

Event Description

It was reported that the pt started experiencing a rash on his body.On (b)(6) 2014, the rash became worse.Sometime later, date not reported, the pt experienced pain all over.On (b)(6) 2014, the pt stopped taking his steroids.On (b)(6) 2014, the pt called pd nurse and stated "he was not feeling well." on (b)(6) 2014, the pt went to the hosp with low blood pressure and arrhythmias.Cause of the low blood pressure and arrhythmias was unk.No details of the pt's treatment were provided.Reportedly, the pt passed away on (b)(6) 2014, cause of death was cardiac related, but not confirmed.

Manufacturer Narrative

This report is being submitted as part of a system level review, which will include an investigation of all potential fresenius products being used at the time of the event.A supplemental report will be submitted upon final review of medical records by post market clinical physician and completion of the plant's investigation.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE; 4040 nelson ave; concord CA 94520
• Manufacturer Contact: corie vazquez, mgr ; 920 winter st; waltham, MA 02451-1457 ; 7816999017
• MDR Report Key: 4110920
• MDR Text Key: 4838036
• Report Number: 2937457-2014-02661
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2014
• Is this an Adverse Event Report?: Yes
• 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: 08/12/2014
• 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): Death
• Patient Age: 69 YR