Prismaflex 7.XX 의 리콜

Recall

79965

Class 2

Z-1925-2018

2018-04-24

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164046

Baxter healthcare will be installing new firmware on all prismaflex control units to address the potential for a small number of these units to exhibit a failure mode with the pump module electronics. the failure mode may result in a voltage out of range malfunction alarm, which causes the device to enter a safe state and become inoperable until it is serviced. baxter will be releasing new firmware that will prevent the malfunction from occurring.

The firm, Baxter, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated 4/24/2018 to its customers. The letter explained the reason for the recall and provided the following direction: "Operators may continue to safely use Prismaflex control units that have not exhibited the Voltage Out of Range malfunction alarm. A local Baxter service representative will contact your facility to determine the correction plan and schedule the firmware upgrade. Your facility will be receiving this firmware upgrade from Baxter at no charge. f you purchased this product directly from Baxter, complete the enclosed Baxter Customer Reply Form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com, even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt of this notification and prevent you from receiving repeat notices. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please notify your customers of this Urgent Medical Device Correction in accordance with your customary procedures." If you have any questions, call Baxter Corporate Product Surveillance at 800-437-5176 between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday or Email Baxter at: corporate_product_complaints_round_lake@baxter.com.