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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
Device Problems No Display / Image; Device Inoperable; Noise, Audible
Event Date 02/24/2015
Event Type  Injury  
Event Description

A continuous cycling peritoneal dialysis (ccpd) patient's registered nurse (rn) called technical support requesting a replacement cycler. She stated that when she turned on the device, it made a frying sound and the screen was blank. The pt was then advised to complete manual exchanges while waiting for the replacement. Upon follow up contact with the patient's peritoneal dialysis rn (pdrn), she stated that the pt was admitted to the hosp on (b)(6) 2015 for shortness of breath and fluid overload due to the inability to use the cycler. The pt was discharged from the hosp on (b)(6) 2015 in stable condition and pt continues with the ccpd program. Pt med records have been requested.

 
Manufacturer Narrative

Based on the info provided, it is unk how the device may have caused or contributed to the event. The pt has been trained and was advised by the pdrn to complete manual exchanges while waiting for the replacement cycler. The post market surveillance dep requested the patient's med records. A supplemental medwatch report will be submitted upon completion of the clinical and device investigations.

 
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Brand NameLIBERTY CYCLER
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
concord CA
Manufacturer Contact
jerry succuro, ccht, ma
920 winter st
waltham , MA 02451-1457
7816970376
MDR Report Key4634831
Report Number2937457-2015-00394
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type Consumer,Health Professional,User facility
Reporter Occupation
Type of Report Initial
Report Date 02/24/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2015
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
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/24/2015
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/01/2010
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: 03/25/2015 Patient Sequence Number: 1
Treatment
LIBERTY CYCLER SET
FRESENIUS PD SOLUTION
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