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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA DLIBERTY CYCLER
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FRESENIUS MEDICAL CARE NORTH AMERICA DLIBERTY CYCLER Back to Search Results
Device Problem Device Alarm System (1012)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 06/01/2011
Event Type  Injury  
Event Description
It was reported that a peritoneal dialysis (pd) patient reported being "very sick" and needed to get rest because he was not (rested) before due to alarms.The patient's doctor took him off the machine for now.He is currently doing manuals.
 
Manufacturer Narrative
This is a retrospective mdr being submitted by fresenius medical care as a remediation action committed to fda regarding all market preference evaluation (mpe) surveys conducted between 2011 thru 2013.The lack of information provided within survey responses does not allow any additional information to be collected from the end user.The mpe surveys include all relevant and related event information.No further information is expected.
 
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Brand Name
DLIBERTY CYCLER
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
concord CA
Manufacturer (Section G)
FRESENIUS MEDICAL CARE NORTH AMERICA
2637 shadelands dr.
walnut creek CA 94598
Manufacturer Contact
tanya taft, cnor, rn
920 winter st.
waltham, MA 02451-1457
7816999000
MDR Report Key4360315
MDR Text Key5236653
Report Number2937457-2014-03442
Device Sequence Number1
Product Code FKX
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Type of Report Initial
Report Date 06/01/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received06/01/2011
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
LIBERTY CYCLER CASSETTE; DELFLEX PD SOLUTIONS
Patient Outcome(s) Other;
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