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 High Blood Pressure/ Hypertension (1908); Nausea (1970); Tachycardia (2095); Loss of consciousness (2418)

Event Date 10/31/2012

Event Type  Injury  

Event Description

On (b)(6) 2012, this pt's dialysis started at 6:22.At 6:36, the pt stated "i feel funny." the nurse attempted to replace the blood pressure cuff (it was loose) when the pt began to wretch and then became unresponsive.Her blood pressure was 206/131 and pulse 140.The nurse administered 400 ml normal saline.Pt was responsive within 1 minute after fluid administration.Ultra filtration was left off.The pt completed treatment without further events and was discharged ambulatory.

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 1925 pages of med records info it appears that on (b)(6) 2012 this pt became non responsive during her dialysis treatment.The nurse intervened and the pt was responsive in about one minute.The pt was discharged after treatment was completed.This pt has a well documented med history of hypertension and tachycardia.There is no documentation in the med record that shows a causal relationship between the pt's dialysis treatment or dialysis products and the pt's unresponsive episode, tachycardia or hypertension.In addition, this pt has an extensive med history of not taking medications or attending treatment.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): 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: 4548473
• MDR Text Key: 17226788
• Report Number: 8030665-2015-00095
• 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: GRANUFLO; FRESENIUS 2008K; SALINE; NATURALYTE; FRESENIUS COMBISET BLOODLINES; FMC DIALYZER
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 66