Notification Regarding Platelets, Pheresis Collection Using the Gambro Trima Accel Automated Blood Collection System

Product: Gambro Trima Accel Automated Blood Collection System

Manufacturer: Gambro BCT, Inc, Lakewood, Colorado

Product Catalog Numbers: 777800-400 and 777800-450

Reason for the Notice:

Gambro, BCT, Inc. sent a letter to its customers (dated July 22, 2004) providing the following information.

Gambro BCT, Inc. has received an increased number of reports of:

1. Significantly lower yields/concentrations of platelets in Platelets, Pheresis products (single, double, and triple) when manufactured using the Trima Accel Blood Collection System.
2. The leukocyte-reduced plasma product, collected concurrently using Trima Accel, may contain greater than 1 x 10⁶ white blood cells.

The problem appears to be related to a weak connector weld within the separation channel of some tubing sets. Users may continue to use the current lots of tubing sets at this time, but Gambro BCT, Inc. strongly recommends that users perform pre-release platelet counts on the final product.

Risks:

• Donor: There is no evidence of a safety risk for the donor.
• Patient: The efficacy of the product could be less than expected - If platelet products are not assayed prior to release for platelet content, a patient could receive a transfusion with a significantly fewer platelets than expected, creating further exposure when additional products must be administered.

Action Items:

Manufacturers who use the Trima Accel Blood Collection System to collect Platelets, Pheresis products should immediately notify the Gambro BCT Support Center at 1-877-339-4228 or 303-231-4357 if they:

1. Collect products with a significantly lower yield/concentration (70% or less than predicted) or
2. The message "low platelet concentration detected" is displayed during a run.