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

FDA device recall Z-1380-05 · posted 2005-08-18 · Terminated

Recall details

Recalling firm

Baxter Healthcare Renal Div

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KDI

Quantity affected

264 units

Distribution

Nationwide and internationally to China and Belgium

Date initiated

2005-07-13

Date posted

2005-08-18

Date terminated

2008-10-29

Location

Park, IL

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