Following an increased number of reports of hemolysis in leukocyte reduced whole blood and RBC products, the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism met Thursday, December 16, 2004.The task force considered reports received by task force members, as well as by the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) of hemolysis in red blood cells and whole blood products following leukocyte reduction using the BPF4 High Efficiency Filter manufactured by Pall Medical.The hemolysis has been reported both immediately following filtration and after storage.Until all the factors involved have been evaluated the root cause remains undetermined and the investigation continues.The principal concern is the possibility of transfusion of an extensively hemolyzed blood product, which could result in serious injury or death.

At this time, the Task Force urges hospital transfusion services and blood collection facilities to check for hemolysis in every unit in their inventory of filtered Whole Blood and Red Blood Cells (regardless of the filter used or lot number) and to be especially vigilant in their visual examination of product immediately prior to release for transfusion.

If hemolysis is found, hospital transfusion services are asked to quarantine the blood product and to immediately notify their blood supplier.Blood collection facilities that receive reports of hemolysis from their consignees or that identify hemolysis in units in their inventory are asked to quarantine the product and to immediately notify Pall Medical in accord with FDA instructions as reproduced below.

Reporting

To report hemolysis, please immediately call Pall Medical at 1-800-645-6578 with the following:

• Your Facility Name
• Contact Name and Title
• Contact Phone Number (office, fax, mobile and/or pager)
• BPF4 Product Reorder Code(s) Used (430-00, 430-41, 430-45, 430-50 and BPFB)
• For each lot inspected or processed, provide the lot number. (How much of this lot is unused?)
• If hemolysis is seen, specify where (segment, bag, or both) & color. If hemolysis is quantified, specify the method (color chart or assay) and the level
• Frequency (no. of units hemolyzed / no. of units inspected or processed)
• Age of the product at time of filtration
• From the original product container: the manufacturer and the anticoagulant/additive solution
  

To view the full FDA announcement, go to their site.