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

Model Number LIB

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fatigue (1849); Fever (1858); Weakness (2145)

Event Date 07/20/2012

Event Type  Death  

Event Description

It was reported by a patient/user of the fmc dialysis device that she was hospitalized for not feeling well and she thinks it may be cycler related.The patient requested replacement of the cycler.The patient stated that during her treatments she does not remember having any alarms and she felt her treatments ran pretty smooth.

Manufacturer Narrative

The liberty cycler was returned for evaluation; no non-conformities were found.The unit passed all tests during simulated treatment testing and met specifications.A batch record review was conducted and confirmed there were no deviations or non-conformances.Product labeling, material, and process controls were found to be within specifications.The clinical investigation indicates the patient's peritoneal dialysis was not adequate.Per the patient's peritoneal dialysis rn, the patient's issues are more therapy related with possible treatment compliance and peritoneum membrane issues.The patient was not getting enough dialysis.The fmc pharmacovigilance physician states hyperkalemia is usually associated with renal failure; inadequate dialysis may lead to hyperkalemia.Inadequate dialysis may result from incomplete dialysis prescription secondary to noncompliance, prescription adjustments, and or incomplete treatments.There is no report that the device displayed alarms or malfunctions which could result in incomplete treatments.This patient was hospitalized for an asymptomatic event of hyperkalemia.During the hospitalization, patient reported experiencing fevers for the previous 5 days, in association with lymphadenopathy and pancytopenia.This is a retrospective mdr being submitted by fresenius medical care asa remediation action committed to fda regarding all potential adverse events received between (b)(6) 2011 to (b)(6) 2013.

• Brand Name: FRESENIUS 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: 4085268
• MDR Text Key: 20322055
• Report Number: 2937457-2014-02174
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/22/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/22/2012
• Was Device Evaluated by Manufacturer?: Yes
• 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: 32 YR