MAUDE Adverse Event Report: FRESENIUS MED CARE NORTH AMERICA, REYNOSA MFG LIBERTY CYCLER SET

Device Problem Insufficient Information (3190)

Patient Problems Sepsis (2067); Peritonitis (2252)

Event Date 04/01/2009

Event Type  Injury  

Event Description

The plaintiff's atty alleged that the plaintiff experienced multiple instances of peritoneal infections and sepsis on unk dates in (b)(6) 2009 after use of the product.

Manufacturer Narrative

This is one event (peritonitis - sepsis) of two events reported for the same patient involving three separate products.

• Brand Name: LIBERTY CYCLER SET
• Manufacturer (Section D): FRESENIUS MED CARE NORTH AMERICA, REYNOSA MFG; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; brecha e99 sur; parque; industrial reynos, bldg. ii apartado postal 326; cd, reynosa, tamps ; MX
• Manufacturer Contact: corie vazquez ; 920 winter st; waltham, MA 02451 ; 7816999071
• MDR Report Key: 4101094
• MDR Text Key: 16635411
• Report Number: 8030665-2014-00738
• 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: 08/28/2014

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: 08/28/2014
• Initial Date FDA Received: 09/17/2014
• 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