Dialog+ Hemodialysis Systems by B. Braun Medical: Class I Recall - Defective Conductivity Sensors

AUDIENCE: Risk Manager, Nephrology

ISSUE: B. Braun Medical Inc. is recalling the Dialog+ Hemodialysis System due to cracks in conductivity sensors that may allow air to enter into the solution (dialysis fluid or dialysate) used to help filter waste and other excess fluids in the blood. The presence of air in dialysis fluid may lead to improper blood filtration, causing serious adverse health consequences, including death.

The recalled products include

Model numbers: 710200L, 710200K, 710200S, 710200U, 710500L, 710500K
Manufacturing dates: April 1, 2013 to July 3, 2013
Distribution dates: June 25, 2013 to October 7, 2015

BACKGROUND: The Dialog+ Hemodialysis System is a machine used in the treatment of chronic kidney disease for patients whose own kidneys are no longer healthy enough to filter their blood of wastes and excess fluid. These systems are used in hospitals, health centers, and in outpatient dialysis center settings.

RECOMMENDATION: On April 1, 2016, B. Braun Inc. sent an “Urgent Medical Device Correction” letter to affected customers asking them to:

Inform all other potential users about the issue
Identify affected units in their inventory
Have a qualified service technician run a pressure test using the instructions attached with the letter
Tag the machine and continue its use if no drop in pressure was identified
Contact B. Braun Inc. customer service at 1-800-848-2066 for part replacement if air leakage was identified
Return a “Medical Device Correction Acknowledgment” form by email toPA_QualityAssurance.BBMUS_Service@bbraun.com or by fax to 610-849-1197

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch alert, including a link to the FDA Class I Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm499143.htm