MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE LIBERTY CYCLER, DUAL PATIENT CONNECT

Catalog Number 050-87212

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 02/22/2014

Event Type  Death  

Event Description

It was reported by the clinic that the patient expired during pd treatment or just after.It was reported that prior to the event, the patient had been hospitalized for cardiomyopathy, was transferred to a rehab facility and was released on (b)(6) 2014.Additional information has been requested.

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.This event report is related to three separate products and associated with mdr's # 2937457-2014-01020 and 8030665-2014-00472.

• Brand Name: LIBERTY CYCLER, DUAL PATIENT CONNECT
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; waltham MA 02451
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamps CP 8 8780; MX CP 88780
• Manufacturer Contact: corie vazquez, mgr ; 920 winter street; waltham, MA 02451 ; 7816999071
• MDR Report Key: 3913427
• MDR Text Key: 4582703
• Report Number: 8030665-2014-00472
• 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: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DELFLEX; LIBERTY CYCLER
• Patient Outcome(s): Death
• Patient Age: 79 YR
• Patient Weight: 106