MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number RTLR180111

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Myocardial Infarction (1969); Sudden Cardiac Death (2510)

Event Date 02/24/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).The device was not returned to the manufacturer for evaluation.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, the device record review confirmed the labeling, material, and process controls were within specification all pertinent information available to the manufacturer has been provided.

Event Description

It was reported by a patient's wife that a patient on continuous cycling peritoneal dialysis (ccpd) using a fresenius liberty cycler expired from a massive heart attack, which was not related to dialysis treatment.Further information obtained from the patient's pd nurse stated the patient passed away in the middle of the day and was not connected to the cycler.The patient's last treatment was the night before.The patient had several pre-existing heart conditions which contributed to the patient's expiration, per the nurse, however, further details were not provided.The nurse stated the death was not caused or contributed by pd therapy.Medical records were requested but not provided.

• Brand Name: LIBERTY CYCLER
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5574095
• MDR Text Key: 42555152
• Report Number: 2937457-2016-00396
• 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: consumer,health professional
• Type of Report: Initial
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Other Device ID Number: 00840861100972
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2016
• Date Device Manufactured: 07/23/2010
• 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 SET
• Patient Outcome(s): Death
• Patient Age: 76 YR