AK 200 ULTRA S (2016-04-19)

Starting date:

April 19, 2016

Posting date:

May 9, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-58166

• Reason
• Affected products

Affected Products

AK 200 ULTRA S

Reason

Baxter has become aware that some users have not followed the start-up procedures when performing online priming with the AK200 Ultra S. Patients are at risk of receiving priming solution, if the start-up procedures for on-line priming described in the operator's manual are not followed when preparing the AK 200 Ultra S for a patient treatment.  A patient may receive priming solution if the operator/user: fails to properly attach the venous line in the venous clamp during the priming procedure, and fails to verify the illumination of the machine blood path indication after patient connection, and fails to confirm start of treatment.

Affected products