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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
Model Number LIB
Device Problem Insufficient Information (3190)
Patient Problem Pneumonia (2011)
Event Date 11/11/2013
Event Type  Injury  
Event Description
During a follow up phone call the patient stated that they had been admitted to the hospital for pneumonia.
 
Manufacturer Narrative
The actual device was returned to the manufacturer for physical evaluation and determined to be functioning according to product specifications.Further evaluation found no device malfunctions that would have caused the reported event.A batch record review was conducted and confirmed there were no deviation or non-conformances during the manufacturing process.Product labeling, material, and process controls were within specifications.Medical records have been requested.A supplemental report will be submitted upon final review of medical records by the post market clinical department if additional information is obtained.
 
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Brand Name
LIBERTY CYCLER
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
920 winter street
waltham MA 02451
Manufacturer (Section G)
CONCORD PLANT, FRESENIUS MEDICAL CARE NORTH AMERICA
4040 nelson avenue
concord CA 94520
Manufacturer Contact
tanya taft, rn, cnor
920 winter street
waltham, MA 02451
MDR Report Key4337635
MDR Text Key17994925
Report Number2937457-2014-03375
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,Company Representative
Type of Report Initial
Report Date 11/12/2013,11/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberLIB
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/11/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/17/2013
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
DELFLEX; LIBERTY CYCLLER SET
Patient Outcome(s) Hospitalization; Required Intervention;
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