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); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Death (1802)

Event Date 05/27/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).The post market surveillance department is in the process of requesting patient medical records and treatment data information regarding the reported event of death.No information was received of a suspected pyrogen reaction or bacteremia associated with this event.The plant investigation is in progress.A capa was initiated to address this issue.A supplemental medwatch will be submitted with relevant information.

Event Description

A patient's spouse reported via a business reply mail that the patient expired on (b)(6) 2015.The spouse reported the patient's death occurred "shortly after using 2 cases of 14lmlb in her dialysis." no other information was provided.Follow up was attempted with the patient's outpatient dialysis facility for further information however, the facility administrator stated she could not disclose any information.No sample is available.

Manufacturer Narrative

Although requested, medical information and treatment records were not received.A sample was not returned to the manufacturer for evaluation.The investigation revealed lot # 14lmlb010 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.A retrospective review of this lot did not identify any nonconformance reports and/or abnormalities during the production of the sap identified lot that could have caused or contributed to the reported event.

• 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 5 V5; CA J7V 5V5
• Manufacturer (Section G): MONTREAL; 383 joseph-carrier; vaudreuil-dorion J7V 5 V5; CA J7V 5V5
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5354368
• MDR Text Key: 35454508
• Report Number: 1225714-2016-00002
• 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: consumer,health professional
• Reporter Occupation: Patient Family Member or Friend
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• 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
• Device Lot Number: 14LMLB010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/27/2016
• 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: Unknown
• Removal/Correction Number: Z-1827-2015
• Patient Sequence Number: 1
• Patient Outcome(s): Death