Infusion Pumps

Baxter Healthcare Corporation has identified that the AMIA Sharesource User Guide that is used with the AMIA Automated PD System cyclers incorrectly describes the function of the UF (Ultrafiltration) Limit setting as the ending criteria of the cyclers Extra Last Drain Mode. In some locations in the guide, it states that the UF volume achieved must exceed the programmed UF Limit before the cycler will end the Extra Last Drain, allowing the patient to end therapy or proceed to their last fill.

There is a potential for 15% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results.

There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results

There is a potential for >10% under-recovery on Activated Alanine Aminotransferase (A-ALT) samples greater than 1,200 U/L. In addition there is a potential for a >10% shift in patient results with samples containing bilirubin concentrations greater that 31 mg/dL. This could lead to incorrect patient results

There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.

The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury.

Latch mechanism on the Lift-Off foot section of the Affinity Four Birthing Bed is damaged, it could potentially cause the installed foot section to be improperly engaged onto the bed, could result in injury to the user due to a fall.

Exposed to freezing temperatures due to refrigerated truck malfunctions

Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch.

Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples

Exposed to freezing temperatures due to refrigerated truck malfunctions

Exposed to freezing temperatures due to refrigerated truck malfunctions

A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.

Product distributed for use as an In-vitro Diagnostics without FDA clearance

A caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation may resulting in the contents splashing into the user s eyes or onto the infant. Potential harms associated with contact of the liquid inside the pouch are rash, burn and inflammation.

Exposed to freezing temperatures due to refrigerated truck malfunctions

Product distributed for use as an In-vitro Diagnostics without FDA clearance

Exposed to freezing temperatures due to refrigerated truck malfunctions

There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date