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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER
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FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER Back to Search Results
Device Problem Delivery System Issue, No Description (2664)
Patient Problem No Code Available (3191)
Event Date 11/29/2013
Event Type  Injury  
Event Description
On (b)(6) 2013, a peritoneal dialysis (pd) reported to technical support (ts) that she was hospitalized on (b)(6) 2013.Upon follow-up with the pd nurse it was found the patient was hospitalized (b)(6) 2013 for fluid overfill.Upon admission to the hospital the patient was drained manually (exact amount unknown).The patient completed a hemodialysis treatment in the hospital and was released the following day.The patient resumed therapy with a replacement cycler.Medical and treatment records have been requested however not received.This report is currently being investigated.
 
Manufacturer Narrative
A supplemental report will be submitted upon final review by post market clinical physician and completion of the plant's investigation.
 
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Brand Name
LIBERTY CYCLER
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
walnut creek concord CA
Manufacturer (Section G)
FRESENIUS MEDICAL CARE NORTH AMERICA
4040 nelson ave.
concord CA 94520
Manufacturer Contact
tanya taft, rn cnor
920 winter st.
waltham, MA 02451-1457
7816999000
MDR Report Key3576908
MDR Text Key4142995
Report Number2937457-2014-00012
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
PMA/PMN Number
K043363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Type of Report Initial
Report Date 12/06/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/06/2013
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
LIBERTY CYCLER SET
Patient Outcome(s) Hospitalization;
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