Z-0153-06

Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration...

Name: Z-0153-06 Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration...
Creator: Baxter Healthcare Renal Div
Published: 2005-08-29
License: https://open.fda.gov/license/

Baxter Healthcare Renal Div / initiated 2005-08-29 / Terminated / root cause: software

FDA source

Baxter Healthcare Renal Div began a recall of Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division... on 2005-08-29. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0153-06
Status: Terminated
Initiated: 2005-08-29
Posted: 2005-11-16
Terminated: 2008-10-29
Recalling firm: Baxter Healthcare Renal Div
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
Product code: KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
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.
Root cause tag: software
FDA root cause: 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
Product codes and lots: All serial numbers

Product code KDI

K021615Class IIBaxter Accura System, Model 5M5660Baxter Healthcare Corp / cleared 2002-11-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)