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

Catalog Number RTLR180111

Device Problems Device Alarm System (1012); Overfill (2404)

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

Event Date 07/22/2015

Event Type  malfunction  

Manufacturer Narrative

A review of the info available was performed by the post market surveillance department as obtained from the pt.A large intra-peritoneal drain 3 volume occurred with an undetermined cause.There was no adverse event associated with this reported large drain volume.A supplemental medwatch report will be submitted upon completion of the device manufacture's investigation.

Event Description

A continuous cycling peritoneal dialysis (ccpd) pt called technical support regarding a drain complication alarm and draining too slow.During the review of the treatment data provided by the pt at the time of the call it was determined that a large drain three had occurred.Treatment data: drain 0: 708 ml; fill 1: 2203 ml drain 1: 7651 ml; fill 2: 2203 ml drain 2: 2727 ml; fill 3: 2203 ml drain 3: 4517 ml; fill 4: 2203 ml drain 4: 2262 ml; fill 5: 507 ml.Upon follow up with the pt's (b)(6), he stated that he was aware of the pt's large drain and cycler issues.He confirmed that the pt did not experience any pain or discomfort or require any medical intervention as result of the large drain.It was also explained to the pt that constipation and position could cause some cycles to drain more fluid than others.The pt has since been in the clinic for a previously scheduled appointment in stable condition with no concerns.The pt remains with the ccpd program using the replacement cycler.The reported drain volume of 4517 ml was 205% over the expected drain volume which resulted in a reportable device malfunction.

Manufacturer Narrative

The actual device was returned to the mfr for physical eval.External visual inspection.There were no signs of any physical damage with the received cycler.The heater tray/scale was not obstructed.Interior inspection: the right, rear panel bracket threaded fitting had become dislodged from the l-shape bracket.Two simulated treatments were performed using the received cycler, and there were no alarms that occurred 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.An analysis of the results of two simulated treatments showed the two drain volumes were slightly out-of-specification; 3ml and 4ml respectively.The fault was corrected by tarring the load cell.After tarring the load cell, a subsequent simulated treatment was performed and the resulting drain volumes were within tolerance.The initial load cell value was within tolerance.The load cell verification was within tolerance.The valve actuation test, system air leak test, and the pressure sensor verification check passed.A device manufacturing record review was also conducted.The device history record (dhr) review showed- production floor problem report on (b)(6) 2015 (15.5.1) erratic load cell occurred rework-as per liberty cycler rework manual occurred; disconnected j16 and connected j17 sent to (b)(4) on 04/07/2015.Product labeling, material, and process controls were within specifications.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; concord CA
• Manufacturer (Section G): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: jerry succuro, ccht, ma ; 7816970367
• MDR Report Key: 5022512
• MDR Text Key: 24142376
• Report Number: 2937457-2015-01350
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K043636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Followup,Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: RTLR180111
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2009
• 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