MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LIQUID BICARBONATE 4000 FMC 3 BOT/CS; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number 08-4000-LB

Device Problems Nonstandard Device (1420); Microbial Contamination of Device (2303); Insufficient Information (3190)

Patient Problem Sepsis (2067)

Event Date 04/14/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).There has not been a lot number reported and therefore we are unable to conclusively determine if the product was part of a recall.Although, we are unable to obtain the lot number, a sales and shipping search was performed and it was identified that the patient received (4) lots affected by the recall.It is not currently known if the reported event is related to a lot affected by the recall that had been shipped to the complainant.The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.Clinical investigation: the patient medical records were provided by the facility on (b)(6) 2016.A clinical investigation was performed to identify a causal relationship between the hemodialysis treatment and the adverse event.Based on a total of 60 pages of provided patient medical records this (b)(6) old, male, end stage renal disease (esrd) patient has been on home hemodialysis (hhd) therapy every other day, for the past four years.Medical records did not contain hhd treatment records for the month of (b)(6) 2014.Medical records did contain a dialysis rounds note dated (b)(6) 2014.The dialysis adequacy assessment did identify the patient's blood pressure as being too high and addressed this with the patient.The pth level was also reported as too high and noted poor glycemic control of diabetes.The patient's phosphorus level was identified as higher this month then previous month; an adjustment in the patient's medication was made.Additionally, the dialysis round dated (b)(6) 2014 noted that the patient had symptoms of a urinary tract infection and was treated with the antibiotic levaquin (every other day for 5 doses).No medical records for april (b)(6) were received to make a temporal relationship between the patient's sepsis and the exposure to recalled lots of naturalyte liquid bicarbonate.The bacteria in the recalled lots of naturalyte liquid bicarbonate was identified as halomonas (species 1, 2, & 3) a gram negative bacteria.The lab report for the patient's blood culture drawn and reported on (b)(6) 2016 was enterococcus a gram positive cocci indicating two different organisms.Therefore, based on the provided lab cultures, no causal relationship was identified.Additionally, the patient's nurse reported to have pulled the recalled naturalyte liquid bicarbonate lots from the patient prior to any of the lots being used.There is no documentation in the medical record supporting a possible association of reported sepsis and the exposure to recalled lots of naturalyte liquid bicarbonate.This determination is strengthened by the bacterial organisms identified in the lab cultures of the patient's blood and the confirmation from the nurse that the recalled naturalyte liquid bicarbonate lots were pulled from the patient's available stock prior to being used.

Event Description

Medical records from an unrelated event report the patient was prescribed antibiotics for sepsis.Relevant medical records and follow up communication found this to have been diagnosed (b)(6) 2014.The patient had received recalled lots of liquid bicarbonate from the 2014 recall, and it is unknown if they were used by the patient.However, according to the home therapies nurse (htrn), the patient's culture results revealed the presence of halomonas gram negative bacteria, which does not pertain to the recalled naturalyte liquid bicarbonate.The patient has since recovered and was reported as currently doing well.

Manufacturer Narrative

The actual sample involved is not available for evaluation and the specific lot number is not known.A search of shipping records was performed to identify any product lots shipped to the customer three (3) months prior to the event.A retrospective record review of those lots identified one (1) lot (14amlb004) that was part of a recall due to bioburden and endotoxin issues (halomonas species), and was recalled on (b)(6) 2014.A definitive conclusion regarding the involvement of the product and the patient's reported infection can not be confirmed by the manufacturing plant.

• Brand Name: LIQUID BICARBONATE 4000 FMC 3 BOT/CS
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 383 joseph-carrier; vaudreuil-dorion; québec, j7v 5v5 ; CA
• Manufacturer (Section G): FMC MONTREAL - HAEMOTEC INC.; 383 rue joseph-carrier; vaudreuil-dorion; québec, j7v 5v5 ; CA
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 4504243615
• MDR Report Key: 5778480
• MDR Text Key: 49047756
• Report Number: 1225714-2016-00123
• 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: company representative,health
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• 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
• Other Device ID Number: 00840861101931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2016
• 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: Initial
• Removal/Correction Number: Z-1639-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 119