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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NATURALYTE LIQUID SODIUM BICARBONATE

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FRESENIUS MEDICAL CARE NATURALYTE LIQUID SODIUM BICARBONATE Back to Search Results
Model Number 08-4000-LB
Device Problem Microbial Contamination of Device (2303)
Patient Problems Death (1802); Sepsis (2067); Septic Shock (2068)
Event Date 12/25/2013
Event Type  Death  
Manufacturer Narrative
The product has not been returned for analysis. However, the product model and lot numbers were made available. Review of the device history records indicated this lot number is part of a recall for bacterial contamination. Nine retains of the lot (13kmlb004) were tested for microbiological contamination (bioburden). The bioburden tests on the retain samples of the lot yielded one out of spec sample of the nine retains. Although medical records pertaining to this event including the death certificate and, if completed, autopsy report were requested, no further info regarding the reported event is available and a clinical investigation could not be performed. Without the requested add'l info and clinical investigation, no conclusion can be drawn.
 
Event Description
The subject adverse event was reported via a lawsuit. The plaintiff's attorney alleged as part of dialysis treatment the pt experienced sepsis due to exposure to the product (alleged to have bacterial contamination). The pt, subsequently, went into septic shock and was placed on life support. However, the pt expired approx five days later.
 
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Brand NameNATURALYTE
Type of DeviceLIQUID SODIUM BICARBONATE
Manufacturer (Section D)
FRESENIUS MEDICAL CARE
montreal
CA
Manufacturer (Section G)
FRESENIUS MEDICAL CARE MONTREAL
383 joseph-carter
vaudreuil-dorion, qc J7V 5V5
CA J7V 5V5
Manufacturer Contact
corie vazquez
920 winter street
waltham, MA 02451
7816999071
MDR Report Key4758445
MDR Text Key13381783
Report Number1225714-2015-02649
Device Sequence Number1
Product Code KPO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071387
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Remedial Action Recall
Type of Report Initial
Report Date 02/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number08-4000-LB
Device Lot Number13KMLB004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received02/09/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-1639-2014

Patient Treatment Data
Date Received: 05/07/2015 Patient Sequence Number: 1
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