Device Recall Accura System for Blood Filtration 의 리콜

Recall

33260

Class 2

Z-0153-06

2005-08-29

2005-11-16

Terminated

United States

2008-10-29

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41566

A software anomaly that occurs when the reset totals option is selected during cvvhd therapy with a diaylsate flow rate of less than 600 ml/hour, or cvvh therapy with a predilution flow rate of less than 600 ml/hour, causes balance alarms without an obvious cause.

Baxter sent Urgent Device Correction letters dated 8/29/05 to all Accura device customers via first class mail. The letter informed the accounts of the balance alarms without an obvious cause as a result of a software anomaly that occurs when the Reset Totals option is selected during either CVVHD therapy with a diaylsate flow rate of less than 600 mL/hour, or CVVH therapy with a predilution flow rate of less than 600 mL/hour. To reduce the probability of a balance alarm occurring or reoccurring for this reason, the customers were instructed to not press the Reset Totals option when the dialysate/predilution flow rates are less than 600 mL/hour. The letter provided the customers with two options to resolve this alarm: 1) With physician approval, increase the flow rate to at least 600 mL/hour briefly (be sure to select and confirm), and then decrease the flow rate back to the original prescribed rate (be sure to select and confirm), and 2) If the flow rate cannot be adjusted as mentioned in option 1, then the current treatment must be ended and a new treatment initiated. Any questions were referred to the Center for One Baxter at 1-800-422-9837, and additional technical questions were directed to Baxter Global Technical Services at 1-800-553-6898, prompt #3, option 4 for Renal Technical Support.