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

Model Number RTLR180111

Device Problems Fire (1245); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/22/2015

Event Type  malfunction  

Event Description

A peritoneal dialysis (pd) patient contacted technical services and reported she was not able to finish treatment due to smoke damage to her cycler.The pd patient was reportedly in setup when she saw smoke coming from the back of cycler.Follow up was made with the patient's nurse, who stated the patient contacted her to report smoke observed during setup.There were no reported injuries.The nurse stated she advised the patient to unplug the cycler and contact technical services to report the occurrence and request a replacement cycler.The nurse indicated the patient reported light smoke and confirmed visible flames were reported.The nurse confirmed the patient was trained on performing stat drains as well as manual peritoneal dialysis therapy and stated the patient was advised and reverted to continuous ambulatory peritoneal dialysis (capd) treatment when the issue occurred, thus no treatment was missed.The nurse indicated a replacement cycler was delivered, and the patient continued continuous cycler-assisted peritoneal dialysis (ccpd) therapy with the new cycler without further issue.

Manufacturer Narrative

A supplemental report will be submitted upon completion of plant's investigation.

Manufacturer Narrative

An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.External visual inspection no signs of any physical damage.The heater tray/scale was not obstructed.There were indications of infestation on the rear panel of the cycler unit.During a test treatment, an "m01-21 system error - "stalled in machine state for a long time" warning occurred.The cause was a leaking air bag in the cassette door.The bag had a small, approximately 1/8" tear at the seam along the edge of the air bag frame.After replacing a leaking air bag, the simulated treatment was re-started.During the treatment set-up, an m59 (pressure leak) warning occurred.The alarm was cleared and the treatment was continued.The simulated treatment was completed without any further alarms or problems occurring.The valve actuation test, system air leak test and voltage check passed.In the internal, visual inspection of the unit, there were indications of infestation on the top cover of the cycler unit.The device record review confirmed the labeling, material, and process controls were within specification.There were no reported device malfunctions that would have caused the reported event.The reported complaint symptom of a burning smell was not reproduced during testing.There were no unusual odors observed during testing.

Event Description

Update 07/27/2015.Additional information regarding the incident was provided during follow up with the peritoneal dialysis patient, who stated she had been using the machine for one year prior to the occurrence.The cycler was turned on and during setup of the machine a loud popping sound was reported and smoke began coming out from the back of the cycler.The patient confirmed no visible flames or fire were observed, and she was able to successfully unplug the cycler from the wall outlet and the cycler eventually stopped smoking.The cycler was plugged directly into a wall outlet in the patient's bedroom and by the patient's bedside, and a surge protector was plugged into the second plug on the wall outlet for additional electronics.The patient stated the cycler had been plugged into the same outlet since beginning continuous cycler-assisted peritoneal dialysis (ccpd) using the machine and stated there was no water or any other fluid near the alternating current (ac) power connection, and confirmed there were no fluid leaks reported prior to the occurrence.No additional details regarding the type of wall outlet used for the liberty cycler (grounded, gfcl, etc) was provided.The pd patient stated she occasionally cleaned the machine using lysol disinfectant wipes, and confirmed no cleaning or disinfecting solution was used directly on the machine.

• 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 CA 94520
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 4938476
• MDR Text Key: 6257772
• Report Number: 2937457-2015-01279
• 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: Health Professional,User Facility,health professional,use
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: RTLR180111
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 07/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• 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