MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIBERTY CYCLER

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems High Blood Pressure/ Hypertension (1908); Peritonitis (2252)

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.

• Brand Name: LIBERTY 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 Key: 4435702
• MDR Text Key: 15820976
• Report Number: 2937457-2015-00063
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 01/20/2015
• 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 Manufacturer: 01/06/2015
• Date Manufacturer Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PLAQUENIL; PD FLUID; CARVEDILOL; LISINOPRIL; DILTIAZEM; ATORVASTATIN CALCIUM; LIBERTY CYCLER SET; RENVALA; FOLIC ACID
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 74