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

Catalog Number 08-4000-LB

Device Problems Nonstandard Device (1420); Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Sepsis (2067); Septic Shock (2068); No Code Available (3191)

Event Date 04/01/2014

Event Type  Death  

Manufacturer Narrative

(b)(4).A field corrective action was taken for this type of complaint for this product as alleged.However, product-specific information was not provided to confirm whether this product was one of the recalled lots.Additional information has been requested and will be submitted upon receipt accordingly.

Event Description

The subject adverse event was reported via a lawsuit.The plaintiff's attorney alleged that the patient was delivered the product for use in hemodialysis at home three days a week.Shortly after beginning dialysis at home, the patient was admitted to the hospital; it was determined that the patient was experiencing (b)(6).The patient was discharged from the hospital four days after admission and resumed dialysis.After resuming dialysis the patient experienced sepsis, septic shock and expired from cardiac arrest eleven days after the initial hospitalization, all of which is alleged to have been caused by being exposed to the product (alleged to have bacterial contamination).

Manufacturer Narrative

(b)(4).Updated narrative after device evaluation: the product has not been returned for analysis and the product model and lot numbers were not made available.Investigation was conducted for retained samples on lots against which similar allegations have been made.Retains were tested for microbiological contamination (bioburden); the retains were found to be above the current specification for bioburden (<100 cfu/ml).Although medical records pertaining to this event including the death certificate and, if completed, autopsy report were requested, no further information regarding the reported event is available and a clinical investigation could not be performed.Without the requested additional information and clinical investigation, no conclusion can be drawn.Additional information has been requested and will be submitted upon receipt accordingly.

• Brand Name: NATURALYTE
• Type of Device: LIQUID SODIUM BICARBONATE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; 383 joseph-carrier; vaudreuil-dorion, montreal J7V 5 V5; CA J7V 5V5
• Manufacturer (Section G): FRESENIUS MEDICAL CARE MONTREAL; 383 joseph-carrier; vaudreuil-dorion, qc J7V 5 V5; CA J7V 5V5
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5564394
• MDR Text Key: 42227611
• Report Number: 1225714-2016-00110
• 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
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 08-4000-LB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2016
• 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
• Removal/Correction Number: Z-1639-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention