Liberty Cycler Manual



Page 129 A manual exchange is when you connect your catheter extension set to a bag of solution and perform an exchange without using your Liberty Select Cycler. Liberty Select Cycler User’s Guide P/N 480145 Rev A. Page 251 Cleaning your cycler The Liberty Select Cycler is not sterile equipment, however, you should keep your Liberty Select Cycler clean and dry at all times. Clean the exterior surface of your machine using a damp cloth and a diluted (1:100) bleach solution or other suitable hospital disinfectant.

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Fresenius Liberty Cycler Manual


Liberty peritoneal dialysis cycler
FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER PERITONEAL DIALYSIS CYCLERBack to Search Results
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. 5% solutions. Uses 2 five liter bag.

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Liberty Cycler Fresenius


Liberty Pd Cycler Manual

Type of DevicePERITONEAL 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 Key2739195
MDR Text Key3112637
Report Number2937457-2012-00031
Device Sequence Number1
Product Code FKX
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK043363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source TypeConsumer,Health Professional,User facility
Reporter Occupation
Remedial ActionOther
Type of ReportInitial
Report Date08/03/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/30/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberLIBERTY
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/03/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2010
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse