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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER FKX

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FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER FKX Back to Search Results
Device Problems Device Stops Intermittently; Temperature Problem
Event Date 12/03/2014
Event Type  Malfunction  
Event Description

A continuous cycling peritoneal dialysis (ccpd) patient called technical support to report that the cycler was warming the heater bag too much without alarms. Subsequently, he felt a burning sensation when the fluid was infused. Upon f/u with the patient's pdrn, she confirmed that the patient did feel a burning sensation as the fluid was infused. There was no medical intervention of any type during or following this event. The patient did, however, revert back to capd for approx five days to let the perineum rest. She reiterated that there was no serious physical injury to the patient. He has since began the use of the replacement cycler, ccpd, and is completing treatments without any complications/difficulties.

 
Manufacturer Narrative

The post market surveillance dept has reviewed all info available and it is unk how the device may have caused or contributed to the event. There was no physical/serious injury to the patient. 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.

 
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Brand NameLIBERTY CYCLER
Type of DeviceFKX
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
concord CA
Manufacturer (Section G)
FRESENIUS MEDICAL CARE NORTH AMERICA
4040 nelson ave
concord CA 94520
Manufacturer Contact
jerry succuro, ccht, ma
920 winter st
waltham , MA 02451-1457
7816970376
MDR Report Key4379133
Report Number2937457-2014-03586
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type Consumer,Health Professional,User facility
Type of Report Initial
Report Date 12/03/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer12/15/2014
Date Manufacturer Received12/03/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2011
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 12/30/2014 Patient Sequence Number: 1
Treatment
LIBERTY CYCLER SET
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