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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA NATURALYTE; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
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FRESENIUS MEDICAL CARE NORTH AMERICA NATURALYTE; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 03/21/2013
Event Type  Death  
Manufacturer Narrative
(b)(4).This is one of two device reports that are associated with this event.Additional information has been requested and will be submitted upon receipt accordingly.
 
Event Description
The plaintiff's attorney alleged that the patient received dialysis treatment and was subsequently admitted to a hospital ("initial admission").Two days after the initial admission the patient was given dialysis treatment and was found to have experienced a cardiac arrest allegedly caused by the product administered for dialysis treatment.The patient expired as a result of the cardiac arrest twelve days after the initial admission to the hospital.
 
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Brand Name
NATURALYTE
Type of Device
DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
Manufacturer (Section D)
FRESENIUS MEDICAL CARE NORTH AMERICA
920 winter street
waltham MA 02451
Manufacturer (Section G)
CORPORATE
920 winter street
waltham MA 02451
Manufacturer Contact
tanya taft
920 winter st.
waltham, MA 02451
7816999000
MDR Report Key5501898
MDR Text Key40368945
Report Number1225714-2016-00084
Device Sequence Number1
Product Code KPO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K981043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Other
Type of Report Initial
Report Date 03/15/2016
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
Initial Date Manufacturer Received 03/04/2016
Initial Date FDA Received03/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Life Threatening;
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