Important Safety Alerts

Important Safety Alerts

Field Safety Notice: Hospira GemStarâ„¢ Bolus Cord used with Gemstarâ„¢ Pump

22 Mar 2012

It has come to our attention that the Health Canada was aware of problems associated with the GemStar™ Bolus Cord, used with the Gemstar™ Pump manufactured by Hospira Inc.

Post-market incident reports indicate that defects with these cords can lead to failure to deliver, intermittent operation, and unrequested bolus delivery. The Gemstar™ pump has software controls that set a maximum allowable dosage and minimum lockout time. An audible chirp signals for every requested delivery and provides notification to the patient and attendant staff. These safety provisions help to mitigate the potential risk to the patient. The Health Canada has not received any reports of patient injury.

The manufacturer's preliminary investigation suggests that the cord may be damaged by the force applied to remove the cord from the base of the Gemstar™ unit. This may lead to cracking and open circuits or short circuits.

If you are in possession of the product, please contact your supplier for necessary actions.

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