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

Catalog Number (RTLR)180111

Device Problem Overfill (2404)

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

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A peritoneal dialysis (pd) nurse reported a patient experienced drain issues during treatment.The patient remained asymptomatic: drain o: 126ml; fill 1: 1196ml, drain 1: 894ml; fill 2: 1196ml, drain 2: 1033ml; fill 3: 1196ml, drain 3: 1880ml; fill 4: 1196ml, drain 4: 881 ml; fill 5: 1196ml, drain 5: 2270ml.Last fill volume: 0ml.The reported drain volume of 2270 ml was 189 percent over the expected drain volume which resulted in a reportable device malfunction.The patient did not require medical intervention or treatment as a result of the overfill.

Manufacturer Narrative

External visual inspection: no signs of any physical damage.The heater tray/scale was not obstructed.Two simulated treatments were performed using the received cycler, and there were no alarms that occurred during testing.The valve actuation test passed.The system air leak test passed.The patient sensor calibration check passed.The load cell value and load cell verification measurements were out-of-specification.This was repaired by recalibrating the load cell.After recalibrating the load cell, the cycler passed the load cell verification.The internal, visual inspection of the cycler unit found no discrepancies.Per the documented product investigation, there was no indication that the fresenius product caused, contributed to or was a factor in the reported event.

• 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 ; 920 winter st.; waltham, MA 02451-1457 ; 7816999000
• MDR Report Key: 5346809
• MDR Text Key: 35972906
• Report Number: 2937457-2015-01760
• 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,other,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: (RTLR)180111
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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