Voluntary Medical Device Safety Alert: SPECTRA OPTIA APHERESIS SYSTEM
Reminder to Prime Blood Warmers
DATE NOTIFICATION INITIATED:
April 16, 2018
PRODUCT / LOT NUMBER:
Devices Affected: All Spectra Optia Apheresis Systems
TerumoBCT has issued a Voluntary Medical Device Safety Alert for two purposes. To remind Spectra Optia system users of this potential safety hazard: If a blood warmer is attached to a Spectra Optia tubing set and the blood warmer is not primed before use, air could be delivered to a patient. AND to reinforce the actions required to mitigate this risk.
Terumo BCT notes that many Spectra Optia procedures include the option to use a blood warmer. The Spectra Optia operator’s manual instructs operators how to connect and prime a blood warmer when one is used. The operator’s manual also includes warnings about the risk of delivering air to a patient if a blood warmer is not primed. These warnings appear throughout the manual: 1) in the “General procedural warnings” section in the Preface of the operator’s manual, and 2) in the instructions for priming the lines before connecting the patient for each procedure for which a blood warmer is an option.
If an operator did not observe this warning and/or did not follow the instructions in the operator’s manual, this safety hazard could occur.
REASON FOR THE SAFETY ALERT
Terumo BCT has not received any customer reports of air being returned to patients due to an unprimed blood warmer. A blood warmer that is connected between the Spectra Optia tubing set return line and the patient that is not primed could cause a risk.
A blood warmer can be attached to the tubing set either at the beginning of a procedure or during a procedure.
TerumoBCT’s notification provides a number of actions required by healthcare providers and distributors.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.