Recall Z-0946-2008

Reason for recall

Unrecorded Infusion; If the system is powered down or a power failure occurs during a fill cycle, the HomeChoice system may not record the last 1-4 pump strokes infused into the patient when the power is restored. This situation may create a potential unrecorded delivery of approximately 15-60 mL of fluid being infused into the patient.

FDA-determined cause: Device Design

Action taken

Urgent Product Recall letters dated 11/20/07 were sent via first class mail to all of the affected customers, informing them of the potential for overfill if the system is powered down or a power failure occurs during a fill cycle. A Baxter representative will contact the customer to schedule the software update which corects this anomaly. The accounts were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff and home patients. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1. Baxter sent a follow-up letter dated 3/17/08 to the consignees, accompanied by a copy of the 11/20/07 letter. The letter reiterated the information in the 11/20/07 letter, emphasizing the serious consequences of an overfill for neonates and young pediatric patients, and providing information describing the symptoms of excess fluid in the abdomen and steps to be taken if the user suspects overfill of a neonate or young pediatric patient. Baxter requested that Baxter be contacted if an overfill should occur so Baxter can perform a complete investigation into the event. The accounts were requested to complete and return the enclosed Customer Reply Form, indicating that they have disseminated the information to their staff and home patients. Any questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt 1.