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5/23/2001

Software Problem Found in Homerun Infusion Pump

Cheryl A. Thompson

Baxter Healthcare Corp. is recalling the Sabratek 6060 Homerun Infusion pump because of a software problem that could result in a patient receiving more drug than ordered. Pumps with the product code 606000, 606000-40, 606000-40L, or 606000-40I should not be operated in the patient-controlled analgesia (PCA) or intermittent mode unless they have software version AMB 2.06.6, the company said in a letter dated May 10.

The company has found two problems with the software. The first problem involves an anomaly that occurs when the pump is used for PCA, a bolus injection is requested, and there is an occlusion downstream to the device. Upon clearance of the occlusion and delivery of the bolus injection, the software may instruct the pump to continue to deliver fluid at the rate used for the bolus injection rather than the basal rate.

The second anomaly may allow fluid to be delivered to the patient when the pump is set for the intermittent mode of operation and "delay start" is used.

The company recommends that all customers with a 6060 infusion pump and an older version of software arrange for an upgrade to AMB 2.06.6, which was released in late 1998. To check the software version, follow these steps:

  1. Turn on the pump.
  2. Press and hold down the "No" key.
  3. When the word "password" appears, release the "No" key.
  4. Type "100" and press the "Yes" key.
  5. The serial number and date of pump manufacture will appear first, then the software version.

Baxter said that pumps repaired or distributed after Jan. 21, 2000, when the company acquired the product line from Sabratek Corp., contain software version AMB 2.06.6. Pumps serviced by Baxter should have the company's beige inspection-and-test label affixed to the outside of the pump case.

If a pump needs an upgrade in software, the company recommends that the customer disable the PCA and intermittent modes of operation. (Instructions on disabling these two modes of operation can be found in the operator's manual under "Making the Pump Profile Specific"; see the section on "Delivery Options." For assistance, call 800-933-0303 and press "2" for clinical support.)

According to the May 10 letter, customers will be contacted by their Baxter sales representative and asked the status of their 6060 infusion pumps. Customers may call the company at 800-422-9837, Monday through Friday, 8 a.m. to 5 p.m. CST.