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Class 2 Device Recall Accura System for Blood Filtration |
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Date Initiated by Firm |
July 13, 2005 |
Date Posted |
August 18, 2005 |
Recall Status1 |
Terminated 3 on October 29, 2008 |
Recall Number |
Z-1380-05 |
Recall Event ID |
32631 |
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 847-422-9837
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Manufacturer Reason for Recall |
In the event therapy is terminated, as part of routine instrument programming or therapy maintenance, the Accura instrument may experience difficulty in performing a successful self-test (failure) upon an immediate attempt to restart therapy
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FDA Determined Cause 2 |
Device Design |
Action |
Baxter sent Important Product Information letters dated 7/13/05 to all Accura device customers, to the attention of the Director of Nursing, via first class mail. The letter informed the accounts of the on-going investigation into the potential self-test failure associated with the Accura instrument, and provided the customers with steps to follow if they encounter failed instrument self-tests. These guidance steps include:
1) Place the instrument into 'stand-by' mode. Generally, 15 minutes in 'stand-by' mode is sufficient to allow successful instrument self-test procedures. Enter 'stand-by' mode by turning off the power by using the upper power switch, or by selecting 'Accura off' from the user interface. Avoid selecting 'Next treatment' as this immediately puts the Accura into self-test mode.
2) After 15 minute, turn the power on.
3) After successful completion of self-test, resume therapy per the Accura Operator's Manual.
4) If the instrument still does not complete a successful self-test, additional time in 'stand-by' mode may be required. Repeat steps 1-3.
5) If repeated attempts do not yield a successful calibration test, then remove the instrument from service and contact Baxter Global Technical Services.
Any questions were referred to the Center for One Baxter at 1-800-422-9837. |
Quantity in Commerce |
264 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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