baxter PrisMax V2 Quick Start Manual

baxter PrisMax V2 Quick Start Manual Manual pdf 1 page image

FA-2020-064 Baxter is a registered trademark of Baxter International, Inc. Page 1 of 2Urgent Field Safety NoticePrisMax, V2, ROWFA-2020-064Safety AlertJanuary 2021Dear Healthcare ProviderProblemDescriptionIn an effort to keep you informed of important product information that can help ensurethe safe and effective use of our products, Baxter Healthcare is issuing a Safety Alertfor the PrisMax System. Baxter has received reports of users who have confused theacronyms for Pre-Blood Pump (PBP) and Patient Fluid Removal (PFR) when enteringthe prescriptions on the PrisMax Graphical User Interface (GUI).During setup, the user needs to enter the Pre-Blood Pump (PBP) and the Patient FluidRemoval (PFR) flow rates. Please ensure the appropriate values are entered in therespective fields. Color coding and an additional help button are available for furthersupport when entering the prescription. Please confirm the entered Pre-Blood Pumpand Patient Fluid Removal values on the Review screen. Switching these two flowrates may result in excessive fluid removal from the patient.The acronyms for PBP and PFR are defined in the Operator’s Manual as well as duringtherapy on the GUI screen. Refer to the enclosure for details.To ensure patient safety, the device should only be used by a trained operator.AffectedProductProduct Code Product Description Serial Numbers955558 PrisMax V2, ROW AllHazardInvolvedIncorrect therapy settings could lead to unintended excessive fluid removal duringtreatment. This has the potential to lead to hypotension. There have been two reportsof serious injury related to this issue.Actions to beTaken byCustomers1. To ensure patient safety, the device should only be used by a trained operator perthe instructions in the Operator’s Manual. Please ensure that every operator ofthis device is made aware of this Safety Alert.2. If you purchased this product directly from Baxter, complete the enclosedBaxter Customer Reply Form and return it to Baxter by faxing it or scanningit. Returning the customer reply form promptly will confirm your receipt of thisnotification and prevent you from receiving repeat notices.3. If you purchased this product from a distributor, please note that the Baxtercustomer reply form is not applicable. If a reply form is provided by your distributoror wholesaler, please return it to the supplier according to their instructions.4. If you distribute this product to other facilities or departments within your institution,please forward a copy of this communication to them.

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