• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key4548517
MDR Text Key5522149
Report Number8030665-2015-00089
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
SALINE; GRANUFLO; NATURALYTE; VENOFER; FRESENIUS 2008K; FMC DIALYZER; FRESENIUS COMBISET BLOODLINES
Patient Outcome(s) Required Intervention;
Patient Age38 YR
Patient Weight66
-
-