Spectra Optia Apheresis System (2019-07-19)

Starting date:

July 19, 2019

Posting date:

August 7, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70635

Last updated: 2019-08-07

• Reason
• Affected products

Affected Products

Spectra Optia Apheresis System

Reason

On 2019-05-16 complaints entered into Terumo's database identified a trend of reports from the field stating that an alarm rate (T0AirEmbolism) in Optia Gen 2 e-boxes for when the low-level sensor sees air and the safety computer sees the return pump still rotating in the direction of patient were being  triggered without cause. Root cause investigation shows the issue being related to the current pump driver CCA (777200-544) that was implemented with Gen 2 e-box.

Affected products