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

Model Number LIB

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 09/18/2014

Event Type  Injury  

Event Description

The plaintiff's attorney alleged that the patient experienced an infection on an unknown date after the use of the product.

Manufacturer Narrative

This is one event (infection) for this patient involving this product.

Manufacturer Narrative

The attorney alleged that the suspect device was part of a recall.However, product-specific information is not provided and as such it cannot be determined if the device was part of the recall and what z number was assigned.Additional information has been requested and will be submitted upon receipt accordingly.This is one of two device reports for this event.

Event Description

The plaintiff's attorney alleged the patient experienced peritonitis from the use of the product, approximately 7 months after starting peritoneal dialysis.The patient was admitted to the hospital after noting cloudy dialysis fluid, abdominal pain, vomiting and diarrhea.The hospital noted the peritonitis was caused by escherichia coli in dialysate fluid.

• 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: corie vazquez ; 920 winter st.; waltham, MA 02451 ; 7816999071
• MDR Report Key: 4435735
• MDR Text Key: 15911766
• Report Number: 2937457-2015-00057
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Attorney
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

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
• Device Model Number: LIB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 40 YR