SpaceLabs Anesthesia Workstation Recall Issued Due to Death Risk

Federal health officials have determined that problems with SpaceLabs BleaseSirius anesthesia workstations could pose a risk of serious injury or death for patients, resulting in a class I medical device recall. 

SpaceLabs Healthcare, Inc. issued the initial recall October 17, and the FDA categorized the action as a class I recall on Tuesday, which is reserved for medical devices that pose the most serious risk of patient harm if use is continued.

The recall was issued due to a defect in the CAS I/II absorber used in the BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation and accompanying service kits. The action was taken after SpaceLabs Healthcare, Inc., found the bag-to-vent switch in the CAS I/II absorbers may fail due to loose fastening hardware in the absorber.

The United Kingdom based company said the recall may result in a large leak from the absorber circuit while operating in bag mode. This could potentially impede the workstations ability to provide ventilation during bag mode.

As a result of the problems causing the recall, patients make face a risk of severe health side effects, including death.

Anesthesia workstations provide respiratory support to patients who are having trouble breathing or cannot breathe for themselves. The machines deliver oxygen, air and nitrous oxide in a controlled manner to patient-breathing circuits, both with and without the use of a mechanical ventilator.

The SpaceLabs Anesthesia Workstation can be used with a ventilator to deliver anesthetic vapor. It is typically used in hospital settings that do not require mobility.

Alarm functions and vent mode operation may operate properly, according to a company.

The company manufacturers the products in Snoqualmie, WA. All recalled products were manufactured between February 21, 2013, and September 30, 2013, with part numbers 12200900, 12200901, 12200902, 12200903, 14200100 and Service Kits Part Number 050-0659-00 and 050-0901.

SpaceLabs issued a medical device correction letter on November 1, to customers affected by the recall. The company also issued another to international subsidiaries and distributors on November 6, instructing all customers to contact the company if they experience any side effects or problems.

Currently, no known serious injuries or deaths are linked to malfunctions stemming from the recalled products.