MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

Catalog Number 050-87216

Device Problem Insufficient Information (3190)

Patient Problem Edema (1820)

Event Date 09/09/2014

Event Type  Death  

Event Description

It was reported by the clinic that a pt expired during his peritoneal dialysis treatment.The pt received cpr and emergency medical svs were called, pt was transported to the emergency room.Efforts to resuscitate the pt were unsuccessful.

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 and completion of the plant's investigation.This product report is related to two other product reports for the same event.

• Brand Name: LIBERTY CYCLER SET, SINGLE CONN./EXT. DL
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; parque industrial reynosa; reynosa, tamps CP88 780; MX CP88780
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter stg; industrial reynos, bldg. ii; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4229744
• MDR Text Key: 18064426
• Report Number: 8030665-2014-00826
• 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: 09/24/2014

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 050-87216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2014
• 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: LIBERTY CYCLER DELFLEX SOLUTION
• Patient Outcome(s): Death
• Patient Age: 79 YR