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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 Problem Incorrect, Inadequate or Imprecise Result or Readings
Event Date 12/09/2014
Event Type  Injury  
Event Description

A peritoneal dialysis (pd) patient reported that he had been discharged from the hospital recently for fluid overload. He stated that his cycler had not been draining his effluent completely. The cycler is being returned for evaluation. During follow up the patient's pd nurse reported the patient was hospitalized (b)(6) 2014 through (b)(6) 2014 for hypervolemia. Review of the medical records indicate the patient was admitted to the hospital for uncontrolled hypertension (systolic in the 200's), hypervolemia, and hyponatremia secondary to hypervolemia. His hypertension was treated with labetolol that was ineffective and needed two doses of hydralazine. While in hospital care the patient's pd effluent was cultured and found to be growing an acinetobacter species with a white blood cell count of 38. He remained asymptomatic for peritonitis. He was treated with cefepime 1g. His pd prescription was adjusted to a higher dextrose concentration to improve his ultra-filtration and better reach his target fluid goals.

 
Manufacturer Narrative

The actual device was returned to the manufacturer for physical evaluation. Visual examination found the front panel bezel gasket was drooping approximately 0. 25 inches over the center of the front panel overlay. This would not impact the devices performance. Simulated use testing was performed and the device performed as expected. System tests of the components did not find any failures. No devic failure was detected. The evaluation could not confirm the reported problem. A serious injury has occured to a peritoneal dialysis patient following treatment with a cycler. A supplemental report will be submitted upon completion of evaluation by the post market clinical department.

 
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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 ave.
concord CA 94520
Manufacturer Contact
tanya taft, rn cnor
920 winter st.
waltham , MA 02451-1457
7816999000
MDR Report Key4435702
Report Number2937457-2015-00063
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type Consumer,Health Professional
Type of Report Initial
Report Date 12/17/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/06/2015
Date Manufacturer Received12/17/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2010
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: 01/20/2015 Patient Sequence Number: 1
Treatment
PLAQUENIL
PD FLUID
CARVEDILOL
LISINOPRIL
DILTIAZEM
ATORVASTATIN CALCIUM
LIBERTY CYCLER SET
RENVALA
FOLIC ACID
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