MAUDE Adverse Event Report: MONTREAL LIQUID BICARBONATE 4000 FMC 3 BOT/CS; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Catalog Number	08-4000-LB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Death (1802); Septic Shock (2068)
Date of Event	05/02/2014
Type of Reportable Event	Death
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.Clinical investigation: a clinical investigation was performed to identify whether a causal relationship exists between the hemodialysis (hd) treatment and the adverse event.However, any possible association between the naturalyte liquid bicarbonate concentrate and the events of cardiac arrest (on an unknown date) and septic shock (on an unknown date), and subsequent expiration of the patient on (b)(6) 2014 cannot be determined based on the lack of information provided.Additional information related to the patients demographics, medical and surgical history, comorbidities, hospital course, labs, medical testing, concomitant medical products, hd treatment dates, death certificate and/or autopsy report is needed to determine potential causality.
Event or Problem Description
The plaintiff's attorney alleged that the decedent experienced cardiac arrest and septic shock, and ultimately expired on (b)(6) 2014, which is alleged to have been due to the use of the naturalyte liquid bicarbonate concentrate product.The plaintiff's attorney reported that the decedent was exposed to naturalyte product that was contaminated with bacteria during their hemodialysis (hd) treatment.
Additional Manufacturer Narrative
Additional information: 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 definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint sample.A shipment history search identified three (3) lots potentially affected by a recall notification (z-1639-2014).A records review was performed on the 3 lots identified.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lots passed all release criteria.A definitive conclusion regarding the involvement of the concentrate product could not be reached without a physical analysis of the dialysate used during the reported event.A retrospective review of the batch production records (bpr) for finished product, delivered to the client, during the specified time frame, failed to identify any non-conformances and/or abnormalities during production that could have caused or contributed to the reported event.Therefore, no evidence of a manufacturing problem exists to substantiate a causal relationship between the concentrate product and the reported event.Naturalyte bicarb carton products are manufactured to meet aami requirements using validated processes, and released based on a determination that the finished product met those requirements.

• Brand Name: LIQUID BICARBONATE 4000 FMC 3 BOT/CS
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): MONTREAL; 383 joseph-carrier; vaudreuil-dorion MA J7V 5 V5; CA J7V 5V5
• MDR Report Key: 6788515
• Report Number: 1225714-2017-00011
• Device Sequence Number: 13478444
• Product Code: KPO
• UDI-Device Identifier: 00840861101931
• UDI-Public: 00840861101931
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K071387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 08-4000-LB
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Received by Manufacturer: 07/13/2017
• Supplement Date Received by Manufacturer: 08/17/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 09/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Hospitalization
• Patient Age: 67 YR