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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 022 05 18 000
Date submitted: 5/7/2018
Manufacturer:Terumo BCT Inc.
Device Type:Spectra Optia Apheresis Systems
Description:Apheresis Units, Blood Donor, Plasma , Therapeutic, Platelet/Plasma Exchange , White Blood Cell
Medical Device Identifier:Apheresis Systems Spectra Optia 61000
Reason of Field Safety Corrective Action:Terumo states that if a blood warmer is attached to the tubing set of the above apheresis systems and the blood warmer is not primed before use, air could be delivered to a patient.
The firm is reinforcing actions required to mitigate this risk. Terumo states 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.
Further details are provided in attached letter.
Remedy Action:Identify any affected systems in your inventory, and verify with Terumo that you have received this notice.
Terumo states that operators must follow good clinical practice during use of the systems, as follows:
•When you configure the use of a blood warmer for the tubing set return line, the instructions to connect the blood warmer are displayed on the screen before you connect the patient. You must prime the blood warmer tubing set before you connect the patient (see Attachment 1, Figures 1 and 2 of the letter).
•In Chapter 6, the "Selecting Procedure Options" section of the operator's manual, follow the updated instructions to indicate the use of a blood warmer during the procedure.
You must prime the blood warmer tubing set before you connect the patient (see Attachment 1, Figures 3 and 4 of the letter).
Athorized Representative/Importer/Distributor:ABDULREHMAN AL GOSAIBI GTB
Report Source:NCMDR
Source Ref. Number:73AF43E4662AF
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Terumo.pdf