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U.S. Department of Health and Human Services

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

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FRESENIUS MED CARE NORTH AMERICA FRESENIUS COMBISET BLOODLINES Back to Search Results
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.
 
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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 Key4548474
MDR Text Key5527029
Report Number8030665-2015-00093
Device Sequence Number1
Product Code FJK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K962081
Number of Events Reported1
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 Received02/25/2015
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 Number1
Treatment
FRESENIUS 2008K; FMC DIALYZER; NATURALYTE; SALINE; GRANUFLO; FRESENIUS COMBISET BLOODLINES
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age38 YR
Patient Weight66
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