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 Death (1802)

Event Date 07/04/2014

Event Type  Death  

Manufacturer Narrative

(b)(4).No product sample was returned to the manufacturer for physical evaluation.The post market surveillance department is in the process of requesting medical records and treatment data sheets in relation to this event.The plant investigation is in process.A supplemental mdr will be submitted at the completion of this activity.

Event Description

On (b)(6) 2016, while performing a routine effectiveness check, the patient's daughter reported that the patient expired on (b)(6) 2014.No further information was provided.The clinic associated with the patient's home treatments was contacted in an attempt to gather additional information related to the series of events leading to and the exact circumstances surrounding the patient's death.Follow-up was provided by a nurse at the user facility who revealed that the patient had gone in-center for treatment, and then to the hospital.The cause of the patient going to the hospital is not known.The date of the patient's final hemodialysis (hd) treatment is unknown.The patient received lots of bicarb concentrate associated with active recall in (b)(6) 2014.It could not be confirmed if these lots were removed, or if any of the product had been used prior to the patient's death.No further event or patient details were able to be provided.No complaint sample was available to be returned to the manufacturer for evaluation due to the amount of time that had elapsed since the event.

Manufacturer Narrative

Additional information - other relevant history.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 occurrence date.A retrospective record review of those lots identified one (1) lot (14dmlb003) that was part of a recall due to bioburden and endotoxin issues (dietzia species), and was recalled on may 15, 2015.A definitive conclusion regarding the involvement of the product could not be reached without a physical examination of a complaint sample.Therefore, the manufacturing plant was not able to confirm a possible association between the naturalyte liquid bicarbonate concentrate product and the patient death.The post market surveillance department has received patient medical records and treatment data sheets for review.A clinical investigation (ci) is in process.A supplemental mdr will be submitted upon completion of this activity.

Manufacturer Narrative

Clinical investigation: the patient medical records were provided by the facility on august 15, 2016.A clinical investigation was performed to identify a causal relationship between the hd treatment and the patient expiration.Based on the provided medical records, an (b)(6), female end stage renal disease (esrd) patient on chronic in-home hd treatments, who began hd therapy on an unknown date, expired on (b)(6) 2014.The patient had a significant medical history which included esrd, anemia-esrd, cardiac arrhythmias, anemia-iron deficiency-unspecific, congestive heart failure, hypophosphatemia, diabetes mellitus type 2, renal osteodystrophy as well as life sustaining measures of a mechanical ventilator and feeding tube.Additionally, the patient takes a number of medications related to her comorbidities.The documentation within the received medical records covered the time period of (b)(6) 2014 though (b)(6) 2014.The patient expired on (b)(6) 2014.Medical records were not received for the time period beginning (b)(6) 2014 up until the patient's expiration.Consequently, no conclusion could be made to confirm the existence of a causal relationship between the recalled liquid bicarbonate and the patient's death without medical documentation for the stated time period.

• 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 rue joseph-carrier; vaudreuil-dorion, qc, j7v 5v5 ; CA
• Manufacturer (Section G): HAEMOTEC INC. - DIV. OF FMC; 383 joseph-carrier; vaudreuil-dorion, qc, j7v 5v5 ; CA
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5811964
• MDR Text Key: 50095430
• Report Number: 1225714-2016-00128
• 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
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• 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?: No
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-1827-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 83 YR