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

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  

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.

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.

• Brand Name: NATURALYTE
• Type of Device: LIQUID 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 Key: 4758445
• MDR Text Key: 5888408
• Report Number: 1225714-2015-02649
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071387
• Number of Events Reported: 1
• 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 Received: 05/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 08-4000-LB
• Device Lot Number: 13KMLB004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown
• Removal/Correction Number: Z-1639-2014

Patient Treatment Data

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