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)

Patient Problem Sepsis (2067)

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 unknown if the patient's report is related to the lot shipped within the recall.A plant investigation is in process.A supplemental mdr will be submitted upon the completion of this activity.Clinical investigation: the patient medical records were provided by the facility on june 8, 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 medical records information it appears that this (b)(6) male esrd patient on home hemodialysis (hhd) therapy every other day, has been on dialysis therapy for four years.Medical records contain hhd treatment records for (b)(6) 2015.In which this patient completed his hhd as scheduled with no adverse events documented.Additionally it is documented that the patient has not been hospitalized prior to any of these treatments.Medical records contain a history and physical (h&p) for an unrelated hospital admission ((b)(6) 2015) with the chief complaint of severe secondary hypoparathyroidism, which he was scheduled for a partial parathyroidectomy.Medical records did contain an antibiotic order for vancomycin hcl 1000mg iv 2 times a week times 2 weeks, but the date of this entry was not specified as well as the indication of ¿sepsis, unspecified.¿ a follow up correspondence with the patient's home hemodialysis nurse, stated the patient was hospitalized in (b)(6) 2015 with sepsis and the antibiotics were prescribed were for that time period.Medical records did not contain any documentation related to patient's hospitalization in (b)(6) of 2015 for sepsis.There is no documentation in the medical record supporting a possible association of reported illness and the exposure to recalled lots of naturalyte liquid bicarbonate.Particularly in light of the nurse stating the patient was never exposed as she had pulled the recalled naturalyte liquid bicarbonate lots from the patient before he could use them.

Event Description

A patient reported becoming sick after being exposed to recalled lots of naturalyte liquid bicarbonate in (b)(6) of 2015.The patient reported being prescribed antibiotics as a result.Initial follow up correspondence with the patient's home hemodialysis nurse found no substantiation to back up the patient's claim of becoming sick from recalled liquid bicarbonate lots.Medical records surrounding this time period were obtained.Upon review, a prescription for antibiotics for sepsis was found.A second follow up was conducted and the nurse discovered new information that indicated the patient had, in fact, been hospitalized with sepsis in 2015 and was prescribed antibiotics as a result.However, the nurse reported to have pulled the recalled naturalyte liquid bicarbonate lots from the patient before he could use them.A request for additional medical records specifically for the reported hospitalization was denied.The patient has since recovered and is doing well.

Manufacturer Narrative

Manufacturing investigation: a sample was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A lot history review was performed of the products shipped to the dialysis center for the three (3) month time frame which immediately preceded the event occurrence date.No information was found and no lots were identified during this review, which sought to identify the lot numbers for all naturalyte liquid sodium bicarbonate products shipped to this account within the selected time frame.As the lot number was not identified by the user facility and since no lot information was identified during the ship history, a manufacturing review was not able to be performed.However, all device history records (dhr) are reviewed and released according to the ¿review and release of device history record¿ standard operating procedure (sop).Product is not released if it does not meet requirements or is nonconforming.Naturalyte liquid sodium bicarbonate is manufactured to meet aami requirements using validated processes, and released based on a determination that the finished product met those requirements.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.

• 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, j7v 5v5 ; CA
• Manufacturer (Section G): MONTREAL; 383 joseph-carrier; vaudreuil-dorion, j7v 5v5 ; CA
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5765723
• MDR Text Key: 48667796
• Report Number: 1225714-2016-00122
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• PMA/PMN Number: K071387
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• 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
• Date Manufacturer Received: 07/18/2016
• 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-2373-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 119