—#42739

Product

Baxter I-Pump Pain Management System infusion pump, product codes 2L3107, 2L3107K and 2L3107R, Baxter Healthcare Corporation, Deerfield, IL 60015

FDA product code: MEA — Pump, Infusion, Pca
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K993387
Affected lot / code info: all serial numbers

Why it was recalled

When infusing at flow rates below 0.5 mL/hr, the upstream occlusion alarm of the pumps may not detect the occlusion.

Root cause (FDA determination)

Other

Action the firm took

Baxter sent Urgent Device Correction letters dated 10/27/05 to the direct accounts on the same date via first class mail. The letters informed the accounts of the potential for air to migrate through the silicone-pumping segment of the sets, which may result in air reaching the patient. Baxter recommended that the users of the I-Pump to enable the upstream occlusion sensor of the pump or to use sets containing air-elimination filters if the occlusion sensor is disabled or otherwise not activated. Baxter also recommended that for delivery routes other than epidural and subcutaneous at flow rates below 0.5 mL/hr, infusions should always be performed using a set containing an air eliminating filter (product codes 2L3513, 2L3520, 2L3523, 2L3525, 2L3526 and 2L3527). For users of the APII Pump Baxter recommended that all infusions on the APII, for delivery routes other than epidural and subcutaneous, should be performed using a set containing and air-eliminating filter. Baxter sets not containing an air-eliminating filter (product codes 2L3510 and 2L3511) should not be used with the APII device, and should not be used with the I-Pump when infusing at rates less than 0.5 mL/hr. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter sent a follow-up recall letter to the accounts on 6/21/06, providing them with an Operator's Manual Addendum for the AP II Infusion Pump, with the warning to use only Baxter sets with air-eliminating filters with the AP II pump to avoid undetected air-in-line at low flow rates. The accounts were requested to complete and fax back to Baxter the enclosed reply form, indicating the number of additional copies of the addendum needed.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Nationwide, including Puerto Rico, and internationally to Canada, Chile and China

Timeline

Recall initiated: 2005-10-27
Posted by FDA: 2006-04-26
Terminated: 2008-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #42739. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.