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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)
Event Date 01/30/2013
Event Type  Injury  
Event Description
On (b)(6) 2013, dialysis started at 6:37 and was stopped at 8:00.Med records show that the pt's dialysis was stopped early because her blood pressure dropped and she became non responsive with her eyes open.Pt was administered saline and pt was able to talk and stated she was feeling okay.The needles were pulled and the pressure was held.The pt was discharged stable after refusing treatment to be restarted.The blood pressure at the time of this event was 151/80.Her pulse was 81.Blood pressure pre treatment was 149/92.Pulse was 96.
 
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's blood pressure dropped and she became unresponsive during her dialysis treatment.Pt recovered but refused treatment to be resumed and was discharged.There is no documentation in the med record that shows a causal relationship between the pt's hemodialysis treatment and equipment and the pt's unresponsive 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 Key4548494
MDR Text Key18000763
Report Number8030665-2015-00092
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; FRESENIUS COMBISET BLOODLINES; NATURALYTE; FRESENIUS 2008K; VENOFER; GRANUFLO; FMC DIALYZER
Patient Outcome(s) Required Intervention;
Patient Age38 YR
Patient Weight66
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