MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE LIBERTY CYCLER

Model Number LIB

Device Problems Device Issue (2379); Expulsion (2933)

Patient Problems Dementia (1808); Encephalopathy (1833); Hypervolemia (2664)

Event Date 11/20/2015

Event Type  Injury  

Manufacturer Narrative

The plant and medical review investigation has not yet been completed.A follow up report will be filed upon completion of the investigations.

Event Description

A peritoneal dialysis (pd) patient reported they were just released from the hospital.Upon follow up with the patient's clinic, it was indicated the patient was hospitalized for inadequate dialysis and altered mental state.The patient was performing treatment daily and performing four exchanges a day on the cycler.After the patient's hospitalization, the patient's physician added an additional dwell and day-time exchange to the patient's dialysis treatments and the patients physical and metal state have improved.No other medical intervention was required.

Manufacturer Narrative

A return product investigation was not performed as the cycler was not placed in the complaint for the reported symptoms.Field service investigation is not performed on cyclers.In addition, the device history review confirmed the labeling, material, and process controls were within spec.Medical records are clear that the source of altered mental status was not definitely determined.There was no documentation in the medical record that indicated there was a causal relationship between the pt's liberty cycler and peritoneal dialysis solution and the pt's encephalopathy.It appears according to the medical record that the change in pd might have contributed to the pt's encephalopathy.Dementia and a change in memory loss prior to hospitalization in addition to acute encephalopathy are likely contributors to the change in mental status for this hospital admission.

Event Description

Patient is (b)(6) male who presented to the hospital with altered mental status.During the previous eight days, the pt changed from continuous ambulatory peritoneal dialysis (capd) five times per day to nightly continuous cycling peritoneal dialysis (ccpd).The pt's wife stated that this change in the pt's peritoneal dialysis had led to lower output.Pt's discharge diagnosis was acute encephalopathy, likely uremic.Pt received manual dialysis exchanges every four hours while in the hospital and improved and was discharged (b)(6) 2014.

• Brand Name: LIBERTY CYCLER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE ; 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 ; 8006621237
• MDR Report Key: 5331962
• MDR Text Key: 34708626
• Report Number: 2937457-2015-01733
• 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: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIB
• Other Device ID Number: 840861100972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2011
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 78 YR
• Patient Weight: 73