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 Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418); Shaking/Tremors (2515)

Event Date 10/11/2013

Event Type  Injury  

Event Description

On (b)(6) 2013 the pt started her dialysis treatment at 6:20.At approx 8:00 the pt was sent to the emergency room for a seizure/syncope like episode and was non responsive.During this episode the pt's bp dropped from 179/105 to 58/20 in 3 minutes.Staff administered 600 cc of normal saline.The pt was returned from the emergency room shortly afterwards to the clinic and dialysis treatment was completed.Pt was then discharged.

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) 2013, the pt had a non responsive and hypotensive episode during dialysis.The pt was sent to the emergency room and sent back to the dialysis clinic.Treatment was completed and the pt was discharged.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 non responsive or hypotensive episode.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: 4548474
• MDR Text Key: 5527029
• Report Number: 8030665-2015-00093
• 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

• 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: 01/30/2015
• Initial Date FDA Received: 02/25/2015
• 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: FRESENIUS 2008K; FMC DIALYZER; NATURALYTE; SALINE; GRANUFLO; FRESENIUS COMBISET BLOODLINES
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR
• Patient Weight: 66