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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 Failure to Cycle
Event Date 07/05/2011
Event Type  Injury  
Event Description

A peritoneal dialysis patient's wife called fresenius technical support regarding many drain complication alarms and an m31 air cassette alarm occuring last night. The patient was able to complete treatment. She opened the door to remove the cassette and noticed a lot of moisture on the pump as well as the cassette. During a follow-up call, the pd nurse stated that the patient went to the hospital for severe peritonitis and chest pain. Pd treatment was discontinued and the pd catheter was removed.

 
Manufacturer Narrative

A product investigation was performed for this device. A visual inspection confirmed there was dried fluid inside the cassette compartment and underneath the mushroom heads. During a stimulated treatment the reported drain complication alarms were verified, due to fluid in the pneumatic system. The device passed the mushroom head inspections. The leak was contributed to the cassette. A device history record review was performed for this device. There was no unexpected variances, or adjustments or comments noted in the device records. A search in the complaint tracking system listed no other drain complications, m31 air in the cassette, or fluid leak complaints for this device. A review was performed by the post market clinical department. Per the pharmacovigilance physician the event of peritonitis is unlikely related to the liberty cycler machine. At the time of the event there were no further fluid leaks or any other machine malfunction. Peritonitis in a patient undergoing peritoneal dialysis is most often due to contamination with pathogenic skin bacteria resulting form touch contamination or catheter related infection. There was also a complaint of chest pain but sufficient information, medical records and treatment sheets were not available for review. It is reported the patient is currently on hemodialysis and is doing well. This is a retrospective mdr being submitted by fresenius medical care as a remediation action committed to fda regarding all potential adverse events received between (b)(6) 2011 to (b)(6) 2013.

 
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Brand NameLIBERTY CYCLER
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
concord CA
Manufacturer (Section G)
WALNUT CREEK PLANT
4040 nelson ave.
concord CA 94520
Manufacturer Contact
tanya taft, rn, cnor
920 winter st.
waltham , MA 02451-1457
7816999000
MDR Report Key4072091
Report Number2937457-2014-02419
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type Other,Consumer
Type of Report Initial
Report Date 07/05/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/29/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberLIB
Device Catalogue Number180020
Was Device Available For Evaluation? Yes
Date Manufacturer Received07/05/2011
Was Device Evaluated By Manufacturer? Yes
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: 08/29/2014 Patient Sequence Number: 1
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