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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE LIBERTY CYCLER

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FRESENIUS MEDICAL CARE LIBERTY CYCLER Back to Search Results
Device Problem Temperature Problem
Event Date 10/09/2014
Event Type  Injury  
Event Description

Patient called htrn, (b)(6), to report cycler malfunction. Patient stated that her liberty cycler gave her an alarm that the solution was too hot and needed to cool down. She states that she then felt burning in her lower abdomen, groin and upper thighs. She had already called technical support, who advised her to call her nurse afer walking her through the procedures to drain and disconnect safely from the machine. She said technical support told her not to use the cycler anymore and they would be sending another to her the next morning. The patient was advised to go to the er by rn. Patient was discharged from er without significant findings. Home therapy program manager, medical director, md, director of operations, and regional quality manager notified. Patient was called to follow up after er visit by kathy, htrn, and patient told her at that time that she had been feeling "warmer and warmer" over the last two weeks, but didn't report it because she thought she might have an infection. Htrn to continue to follow up with patient and, per md order, will draw blood cultures if patient has any indication at next clinic visit ((b)(6) 2014).

 
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Brand NameLIBERTY CYCLER
Type of DeviceLIBERTY CYCLER
Manufacturer (Section D)
FRESENIUS MEDICAL CARE
2637 shadelands dr.
walnut creek CA 94598
MDR Report Key4329792
Report Number4329792
Device Sequence Number1
Product CodeFKX
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 10/10/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/10/2014
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 Returned to Manufacturer10/10/2014
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/10/2014
Distributor Facility Aware Date10/09/2014
Event Location Home
Date Report TO Manufacturer10/10/2014
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 10/10/2014 Patient Sequence Number: 1
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