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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 Alarm System; Overfill; Noise, Audible
Event Date 01/26/2015
Event Type  Malfunction  
Event Description

A continuous cycling peritoneal dialysis (ccpd) rn called tech support and requested a replacement cycler for the patient. There have been many drain alarms with slow drains. She added that the cycler was very noisy. On review of treatment data obtained from the cycler, a large drain 4 was discovered: 1906ml. There was no complaint of discomfort or pain. Treatment data provided below: attempts to contact the patient's reporting pdrn have been unsuccessful. No additional event info is available at this time. The reported drain volume of 1906ml was 191% over the expected drain volume which resulted in a reportable device malfunction.

 
Manufacturer Narrative

A review of the info available was performed by the post market surveillance dept. A large intra-peritoneal drain 4 occurred with an undetermined cause. There was no adverse event reported with this large drain volume. A supplemental medwatch report will be submitted upon completion of the device investigation.

 
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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 Key4711604
Report Number2937457-2015-00531
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type Consumer,Health Professional,User facility
Reporter Occupation
Type of Report Initial
Report Date 02/10/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/20/2015
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
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/10/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured11/01/2009
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: 04/20/2015 Patient Sequence Number: 1
Treatment
FRESENIUS PD SOLUTION
LIBERTY CYCLER SET,
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