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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA GRANUFLO

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FRESENIUS MEDICAL CARE NORTH AMERICA GRANUFLO Back to Search Results
Device Problem Insufficient Information
Event Date 03/14/2008
Event Type  Death  
Event Description

The plaintiff's attorney alleged that the pt experienced a sudden cardiac event and subsequently expired on the same day. It was reported that the death occurred due to administration of naturalyte and/or granuflo during dialysis treatment.

 
Manufacturer Narrative

This is one event (death) for the same pt involving two separate products.

 
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Brand NameGRANUFLO
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
waltham MA
Manufacturer Contact
corie vazquez
920 winter street
waltham , MA 02451
7816999071
MDR Report Key4640877
Report Number1225714-2015-01513
Device Sequence Number1
Product CodeKPO
Report Source Manufacturer
Source Type Consumer
Reporter Occupation ATTORNEY
Type of Report Initial
Report Date 03/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/27/2015
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
Date Manufacturer Received03/20/2015
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 Invalid Data

Patient TREATMENT DATA
Date Received: 03/27/2015 Patient Sequence Number: 1
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