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

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Event Description

The plaintiff's attorney alleged that the plaintiff experienced peritonitis with possible system air leakage on an unknown date after use of the product.

Manufacturer Narrative

This event (peritonitis) is for the same patient involving three separate products.This is report 1 of 4 overall system level reports involved.

• Brand Name: LIBERTY CYCLER SET
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamps 8878 0; MX 88780
• Manufacturer Contact: corie vazquez ; 920 winter st.; waltham, MA 02451 ; 7816999071
• MDR Report Key: 4185733
• MDR Text Key: 19717018
• Report Number: 8030665-2014-00811
• 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
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2014
• Initial Date FDA Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability