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

Device Problem Insufficient Information (3190)

Patient Problem Peritonitis (2252)

Event Date 08/28/2009

Event Type  Injury  

Event Description

The plaintiff's attorney alleged that the plaintiff experienced the following events after the use of the product.On (b)(6) 2007, er visit due to hypotension.On (b)(6) 2008 admitted to the hospital due to kidney hematoma, esrd, bleeding secondary to hematoma, hypersalivation, severe pain, hypertension, and anxiety.On (b)(6) 2009 experienced peritoneal infections and sepsis.On (b)(6) 2009 experienced peritoneal infections, sepsis, metabolic acidosis and hypotension.On (b)(6) 2009 experienced peritonitis.On (b)(6) 2009 experienced peritonitis.On (b)(6) 2010 experienced sepsis with hospitalization.On (b)(6) 2011 er visit due to pyelonephritis.On (b)(6) 2012 er visit due to cold sweat and occipital headaches.On (b)(6) 2012 experienced bacterial fungal peritonitis with left flank pain.The medical records did not have concrete data that any of these event had been caused by fmc products, only that some of them may had been cause by the fact that the patient's dialysis could have had infections.

Manufacturer Narrative

This event (peritonitis) is for the same patient involving three separate products.This is report 1 of 18 total reports involved for the same patient due to pd and hd events.

• 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: 4185730
• MDR Text Key: 5102988
• Report Number: 8030665-2014-00809
• 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: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 08/26/2014
• Initial Date FDA Received: 10/17/2014
• 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 Age: 30 YR