VANTIVE US HEALTHCARE

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using to perform their therapy. As a result, the clinician may think that the patient is receiving the correct prescribed therapy because of what is erroneously displayed on the clinician's remote Sharesource application, when in fact the cycler that is with the patient is actually delivering an outdated and incorrect therapy.

Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles

Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted

Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure