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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
Catalog Number RTLR180111
Device Problem Appropriate Term/Code Not Available
Event Date 04/06/2015
Event Type  Injury  
Manufacturer Narrative

Decide code: (b)(4)- not draining. During the review of the patient's medical records it was discovered that the patient was admitted to icu on (b)(6) 2015 for hypervolemia due in part to drain complications. A supplemental medwatch report will be submitted upon completion of the device investigation.

 
Event Description

During the review of the patient's medical records it was discovered that the patient was admitted to icu on (b)(6) 2015 for hypervolemia due in part to drain complications. The following is from the patient's medical records provided by the treatment facility: the patient is an 81 year old woman who presented to the emergency department due to increasing lower leg edema. She was found to have volume overload. She has also been found to have an active gi bleed that she was not aware of. The patient was found to have an inr of 10. She has treated with oral and iv vitamin k. The pd nurse tried to drain the patient but got back only a few cc's. A quinton catheter has been ordered. She was admitted to icu. She still required hemodialysis and ultrafiltrate managed. Hypertension with volume overload will be addressed with ultrafiltration once hemodialysis access obtained, goal is to uf about 4-5 liters if tolerated.

 
Manufacturer Narrative

The actual device was returned to the mfr for physical evaluation and determined to be functioning according to product specifications. The cycler exterior showed no signs of any physical damage. The heater tray/scale was not obstructed. The simulated treatment was completed without any alarms or problems occurring. The valve actuation test and the system air leak test passed. There were no internal, visual discrepancies found in the inspection of the received cycler unit. There were no device malfunctions that would have caused the reported event. A device manufacturing record review was conducted and confirmed there were no deviations or non-conformances during the manufacturing process. Product labeling, material, and process controls were within specifications.

 
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Brand NameLIBERTY CYCLER
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
concord CA
Manufacturer (Section G)
FRESENIUS MEDICAL CARE NORTH AMERICA
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jerry succuro, ccht, ma
920 winter st.
waltham , MA 02451-1457
7816970376
MDR Report Key5003985
Report Number2937457-2015-01322
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Followup
Report Date 07/14/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/12/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device Catalogue NumberRTLR180111
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/01/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/01/2013
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: 08/12/2015 Patient Sequence Number: 1
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