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 Nausea (1970); Vomiting (2144); Loss of consciousness (2418); Shaking/Tremors (2515)

Event Date 12/30/2012

Event Type  Injury  

Event Description

On (b)(6) 2012, the pt's dialysis treatment started approx 06:06.At approx 06:21, the pt stated she "felt stupid and felt like she was going to be sick." when staff went to get an emesis basin, the pt became unresponsive and started having facial jerking and upper extremity tremors.The staff turned off the ultra filtration and administered 400 cc normal saline.After approx 1 minute, the pt became responsive and had a small greenish yellow emesis.The pt's blood sugar check was 167, her blood pressure was 178/108 and her pulse was 98.Treatment was completed without further incident.Pt was 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) 2012, this pt had an unresponsive episode during her dialysis treatment.This event lasted approx 1 minute.After nursing intervention, the pt eventually became responsive and treatment was completed without further incident.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 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): 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: 4548517
• MDR Text Key: 5522149
• Report Number: 8030665-2015-00089
• 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: SALINE; GRANUFLO; NATURALYTE; VENOFER; FRESENIUS 2008K; FMC DIALYZER; FRESENIUS COMBISET BLOODLINES
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 66