MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE LIBERTY CYCLER, SOFTWARE VER. 2.8.4047; NONE

Model Number LIBERTY CYCLER

Device Problems Alarm, failure of warning (1025); Automatic injection system overinfusion (1046); Excess Flow or Over-Infusion (1311)

Patient Problems Chest Pain (1776); High Blood Pressure/ Hypertension (1908)

Event Date 12/01/2015

Event Type  Injury  

Event Description

Pt using cycler for ccpd treatments at night.Pt hooked up to machine on (b)(6) 2015 and started treatment.In the morning he disconnected and machine read that he had a +547ml ultrafiltration over the course of the treatment.Pt's prescription over the course of the treatment.Pt's prescription is for 4 cycles of 2000ml solution, with last fill of 500ml.According to pt, the machine did not drain him completely after each cycle (one drain was only 1100ml and another only 1500ml and he subsequently was overfilled by the end of treatment.Pt called on-call nurse round 5 pm on (b)(6) 2015 with sbp of 240, pt also had chest pain and sob.On-call nurse told pt to go to er.Pt went to er for treatment.He believed he was overfilled in his peritoneum from ccpd treatment, but was not drained until (b)(6) 2015, when he drained 2000ml.Pt has a high average transport membrane type and would have reabsorbed a large amount of this fluid by the time it was drained, indicating that pts peritoneum was filled above prescribed last fill volume of 500ml and was way above the prescribed max fill volume of 2000ml.This posed a risk of peritoneal leaks or tears.The pt has been released from hospital and has no permanent disabilities or problems, but did have a 6 day hospital stay due to hypertension.Fluid overload was a contributing factor, but exacerbated by overfill on machine.Dose, frequency and route used: daily, 033 intraperitoneal.Diagnosis for use: ersd.

• Brand Name: LIBERTY CYCLER, SOFTWARE VER. 2.8.4047
• Type of Device: NONE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; concord CA
• MDR Report Key: 5364615
• MDR Text Key: 35945418
• Report Number: 5364615
• Device Sequence Number: 1
• Product Code: FKX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIBERTY CYCLER
• Device Catalogue Number: RTLR180111
• Other Device ID Number: UF60601-1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2015
• Distributor Facility Aware Date: 12/01/2015
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 12/09/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 119