Liberty Cycler Manual

Tidal PD was performed using the Home Choice cycler (Baxter Healthcare Corporation, Deerfield, Illinois, U.S.A.) programmed to deliver the prescribed volume overnight, usually over 8 - 9 hours. Fill volumes of 25 - 30 mL/kg were calculated using an adjustment in body weight as previously described (2). Fresenius Liberty Cycler Manual - Fresenius Liberty Cycler Manual Baxter or Fresenius cyclers? - Topic - Congratulations Until this past week I had used a Baxter cycler for the last 3 years. Home therapies - Fresenius Medical Care - The Liberty cycler from Fresenius Renal Technologies is designed to meet the lifestyle and clinical needs of the.

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Liberty Select Cycler Manual

Fresenius Liberty Cycler Manual

FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER

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Model Number LIBERTY

Device Problem Overfill (2404)

Patient Problems Abdominal Pain (1685); Dyspnea (1816); Discomfort (2330); Abdominal Distention (2601)

Event Date 08/03/2012

Event Type Other

Event Description

Pt's peritoneal dialysis nurse called tech support due to pt's report of feeling pain during ccpd treatment and did a manual drain of over 7000 ml. On (b)(6) 2012 per tech support call: pt had an alarm to check cones during set up and no other alarms reported. Drain 0: 538ml, fill 1: 2500 ml, then pt went to sleep. Pt woke up with stomach pain, pt did a manual drain of 7400 ml. Per pd nurse, pt stated feeling okay after draining and no medical interventions were done. Add'l event info: (b)(6) 2012 per pt, the previous treatments went fine but had some 'warning' and 'alarms. ' denied any issues during a day, just prior to incident treatment. During fill 2 of the ccpd treatment, pt felt stomach pain, stomach was large, could not breath, and had discomfort. Treatment was stopped. Pt noted both solution bags were empty (two 1. 5% 5liter bags). Pt disconnected from the cycler and did a manual drain. Pt stated he weighed the manual drain bags after and had drained 6000 ml. Pt denied any other unusual occurrences during the treatment and no power outages days. There is no report of serious injury or that the pt required medical attention. Pt did a couple days of manual treatment while waiting for the replacement cycler.

Manufacturer Narrative

Add'l mfr narrative: device eval will be performed upon cycler's return to the manufacturer. A supplemental report will be sent upon completion of the device eval. On (b)(6) 2012 - per pd nurse (b)(6): pt stated after fill 1 of 2500 ml, he went to sleep. Pt woke up feeling stomach pain and shortness of breath. Pt used two manual drain bags and drained 7400 ml. Dry weight (b)(6). No diabetes, ascites, or fluid overload issues. Pt is still able to urinate a lot. Pt does 4 exchanges with a fill volume of 2500 ml, no last fill or mid day exchange using 1. Gta 3 demo for pc. 5% solutions. Uses 2 five liter bag. Driver pack solutions offline 4gb.

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Liberty Cycler Checklist

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Type of Device

PERITONEAL DIALYSIS CYCLER

Manufacturer (Section D)

FRESENIUS MEDICAL CARE NORTH AMERICA

walnut creek CA

Manufacturer Contact

robert bides, rn, specialist

2637 shadelands dr.

walnut creek, CA 94598

9252950200

MDR Report Key

2739195

MDR Text Key

3112637

Report Number

2937457-2012-00031

Device Sequence Number

Product Code

FKX

Combination Product (Y/N)

Reporter Country Code

PMA/PMN Number

K043363

Number of Events Reported

Summary Report (Y/N)

Report Source

Manufacturer

Source Type

Consumer,Health Professional,User facility

Reporter Occupation

Remedial Action

Other

Type of Report

Initial

Report Date

08/03/2012

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

Date FDA Received

08/30/2012

Is This An Adverse Event Report?

Is This A Product Problem Report?

Yes

Device Operator

LAY USER/PATIENT

Device MODEL Number

LIBERTY

Was Device Available For Evaluation?

Yes

Is The Reporter A Health Professional?

Yes

Event Location

Other

Date Manufacturer Received

08/03/2012

Was Device Evaluated By Manufacturer?

Device Not Returned To Manufacturer

Date Device Manufactured

07/01/2010

Is The Device Single Use?

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Reuse

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