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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 Overfill; Noise, Audible
Event Date 03/18/2015
Event Type  Malfunction  
Event Description

A continuous cycling peritoneal dialysis (ccpd) patient called tech support regarding drain issues during treatment. He also mentioned that the cycler was making a grunting noise during pumping. On review of the treatment data provided by the patient, a large drain 3 was discovered: 3894ml. There was no complaint of discomfort or pain. Treatment data provided below: upon f/u contact with the patient's peritoneal dialysis rn (pdrn), she stated that the patient did not inform her of the event. She added that the patient has been seen in the clinic since the event instable condition and that there was no serious injury or need for medical intervention. The patient continues with the ccpd program. The patient's prescribed treatment fill volume is 2000ml. The reported drain volume of 3894ml was 195% 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 3 occurred with an undetermined cause. There was no adverse event associated with this reported 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 Key4706394
Report Number2937457-2015-00504
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type Consumer,Health Professional,User facility
Type of Report Initial
Report Date 03/18/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/17/2015
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
Date Manufacturer Received03/18/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/01/2011
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: 04/17/2015 Patient Sequence Number: 1
Treatment
LIBERTY CYCLER SET,
FRESENIUS PD SOLUTION
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