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

Catalog Number RTLR180111

Device Problem Device Issue (2379)

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

Event Date 08/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

Event Description

A peritoneal dialysis patient reported that she had just finished draining 8,459ml and expected 2,000ml in drain 0.Patient reported feeling bloated but no pain.Additional medical records have been requested.The reported large drain of 8,459ml was 423% over the expected drain volume which resulted in a reportable device malfunction.

Manufacturer Narrative

Additional information: an external, visual inspection of the returned cycler exterior showed no signs of any physical damage.The heater tray/scale was not obstructed.Two simulated treatments were performed and completed without any alarms or problems occurring.Neither reported complaint system could be reproduced during testing.A simulated treatment was performed in which the amount of fluid delivered to a pseudo-patient bag during each fill phase was weighed.The weighed fluid volumes were compared against the programmed fill value, and the weighed volumes for each fill phase were determined to be within expected tolerance for the liberty cycler.The simulated treatment was performed and completed without any problems occurring.During the treatment test, a groaning or burping sound was observed during pump operation of the cycler.An accelerated stress test identified a weak pump a motor.Grinding noise due to the weak motors was observed during the test.The valve actuation test passed.The system air leak test passed.The patient sensor calibration check passed.The load cell value and verification was within tolerance.There were no internal, visual discrepancies found in the inspection of the received cycler unit.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 history record review confirmed the labeling, material, and process controls were within specification.

• 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): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5964528
• MDR Text Key: 55431765
• Report Number: 2937457-2016-00999
• 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
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Other Device ID Number: 00840861100972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2016
• Initial Date FDA Received: 09/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2011
• 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: DELFLEX PD SOLUTION; LIBERTY CYCLER CASSETTE
• Patient Weight: 77