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
FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER | Back 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. | Search Alerts/Recalls |
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Liberty Peritoneal Dialysis Cycler
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Liberty Cycler Fresenius
Liberty Pd Cycler Manual
Type of Device | PERITONEAL DIALYSIS CYCLER |
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Manufacturer (Section D) | FRESENIUS MEDICAL CARE NORTH AMERICA | walnut creek CA |
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Manufacturer Contact | robert bides, rn, specialist | 2637 shadelands dr. | walnut creek, CA 94598 | 9252950200 |
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MDR Report Key | 2739195 |
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MDR Text Key | 3112637 |
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Report Number | 2937457-2012-00031 |
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Device Sequence Number | 1 |
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Product Code | FKX |
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Combination Product (Y/N) | N |
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Reporter Country Code | US |
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PMA/PMN Number | K043363 |
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Number of Events Reported | 1 |
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Summary Report (Y/N) | N |
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Report Source | Manufacturer |
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Source Type | Consumer,Health Professional,User facility |
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Reporter Occupation |
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Remedial Action | Other |
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Type of Report | Initial |
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Report Date | 08/03/2012 |
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1 Device Was Involved in the Event |
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0 PatientS WERE Involved in the Event: |
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Date FDA Received | 08/30/2012 |
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Is This An Adverse Event Report? | No |
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Is This A Product Problem Report? | Yes |
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Device Operator | LAY USER/PATIENT |
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Device MODEL Number | LIBERTY |
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Was Device Available For Evaluation? | Yes |
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Is The Reporter A Health Professional? | Yes |
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Event Location | Other |
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Date Manufacturer Received | 08/03/2012 |
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Was Device Evaluated By Manufacturer? | Device Not Returned To Manufacturer |
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Date Device Manufactured | 07/01/2010 |
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Is The Device Single Use? | No |
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Is this a Reprocessed and Reused Single-Use Device? | No |
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Type of Device Usage | Reuse |
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