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

Catalog Number (RTLR) 180111

Device Problem Partial Blockage (1065)

Patient Problems Death (1802); Pneumonia (2011)

Event Date 01/29/2015

Event Type  Injury  

Event Description

A peritoneal dialysis nurse called into tech services to have the patient's cycler replaced due to alarms.A follow up call was made to the patient's nurse.Per the nurse the patient was in the hospital at this time for pneumonia.The clinic was made aware of the patient having issues with his cycler at this time, and had called to request a new cycler for the patient.The nurse attempted to gather data from the old cycler, but there was not a lot of information and it was suspected that the patient was not compliant with his therapy.It was decided that the daughter would begin to assist the patient to ensure compliance with treatment.On (b)(6) 2015, while still in the hospital the patient expired.The patient was not connected to the cycler at the time of his passing.The nurse reported that she believed that the hospital was using manual peritoneal dialysis therapy on the patient.The patient was not on the cycler at the time of his death.

Manufacturer Narrative

The cycler was received by the lab for testing.A visual inspection of the returned cycler exterior showed no sign of physical damage.Heater tray was obstructing the cover.During the simulated treatment fc "fill complication encountered" occurred as reported.Troubleshooting the cycler found that the heater tray was obstructing the cover, adjusting the heater tray and calibrated the load cell and performed the second treatment.The symptom lz24 "alarm (unknown)" refer to as fc "fill complication encountered" was confirmed during treatment.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or nonconformances during the manufacturing process.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord plant; concord CA 94520
• Manufacturer Contact: tanya taft, rn cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4562243
• MDR Text Key: 17630706
• Report Number: 2937457-2015-00290
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: (RTLR) 180111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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 TUBING; PD SOLUTION
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention