MAUDE Adverse Event Report: FRESENIUS MED CARE NORTH AMERICA FRESENIUS COMBISET BLOODLINES

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

Patient Problems Syncope (1610); Low Blood Pressure/ Hypotension (1914); Nausea (1970); Loss of consciousness (2418)

Event Date 11/02/2012

Event Type  Injury  

Event Description

On (b)(6) 2012, the pt went to dialysis.Approx 5 minutes after treatment was initiated, the pt complained of "feeling funny." the pt became unresponsive, staring ahead, and grunting.The pt was sent to the er and was admitted to the hosp for syncope.Cardiology and neurology workups were essentially unrevealing.The pt stated she "felt warm and nauseated and passed out." the pt's antihypertensive medications were spread out from once daily dosing to twice a day dosing.The pt was discharged on (b)(6) 2012.

Manufacturer Narrative

This report is being submitted as part of a system level review which will include an investigation of all potential fresenius products being used at the time of the event.Based on the 1925 pages of med records info it appears that on (b)(6) 2012, this pt became unresponsive during her dialysis treatment.The pt was sent to the emergency room and admitted.There is no documentation in the med record that shows a causal relationship between the pt's dialysis treatment or dialysis equipment and the pt's episode of unresponsiveness.Documentation suggests that this episode could be related to autonomic dysfunction and orthostasis during dialysis treatment.The plaintiff's anti-hypertensive medications were adjusted.A supplemental report will be submitted upon completion of the plant's investigation.

• Brand Name: FRESENIUS COMBISET BLOODLINES
• Manufacturer (Section D): FRESENIUS MED CARE NORTH AMERICA; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT, 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: 4548498
• MDR Text Key: 16558913
• Report Number: 8030665-2015-00088
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 01/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• 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
• Date Manufacturer Received: 01/30/2015
• 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
• Treatment: FMC DIALYZER; SALINE; NATURALYTE; GRANUFLO; FRESENIUS COMBISET BLOODLINES; FRESENIUS 2008K
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 37 YR
• Patient Weight: 66