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Class 2 Device Recall Accura System for Blood Filtration |
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Date Initiated by Firm |
August 29, 2005 |
Date Posted |
November 16, 2005 |
Recall Status1 |
Terminated 3 on October 29, 2008 |
Recall Number |
Z-0153-06 |
Recall Event ID |
33260 |
510(K)Number |
K021615
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Product Classification |
Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
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Product |
Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Germany |
Code Information |
All serial numbers |
Recalling Firm/ Manufacturer |
Baxter Healthcare Renal Div 1620 Waukegan Rd Bldg R Mc Gaw Park IL 60085-6730
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For Additional Information Contact |
Center for One Baxter 800-422-9837
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Manufacturer Reason for Recall |
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.
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FDA Determined Cause 2 |
Other |
Action |
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. |
Quantity in Commerce |
255 units |
Distribution |
Nationwide, and internationally to China and Belgium |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = KDI and Original Applicant = BAXTER HEALTHCARE CORP.
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