Potential Hemolysis in Red Blood Cells and Whole Blood
Leukocyte Reduced Products Manufactured with the Pall BPF4 Filter
To: |
Blood Centers Hospital Transfusion Services Healthcare Facilities |
FDA is alerting the healthcare community to the need for vigilance during the examination of leukocyte reduced red blood cell and whole blood products prior to distribution or issuance for transfusion.
Background
FDA has received reports of hemolysis of 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 24 to 48 hours after filtration. Until all the factors involved in the filtration process have been evaluated the root cause remains undetermined. The investigation continues.
Pall has identified the following product codes for increased scrutiny: 430-00, 430-41, 430-45, 430-50 and BPFB.
Recommendations
While the investigation continues, the principal concern is the possibility of transfusion of a hemolyzed blood product, which could result in serious injury or death. Consistent with the recommendations from Pall Medical, we recommend the following steps be taken to minimize risk:
- Review your current inventory of leukocyte reduced Whole Blood and Red Blood Cells filtered using the product codes listed above. Examine the storage bags and attached segments for any evidence of hemolysis. If hemolysis is found, do not distribute or use the product; please call and report the information requested below.
- For units that you are currently processing, and until further notice,
- Carefully read and follow the instructions for use.
- Perform filtration as early as possible following collection.
- Carefully examine all storage bags and attached segments following filtration and immediately prior to distribution. Report hemolysis as instructed below.
- If you distribute leukocyte reduced products manufactured with the Pall BPF4 filter, we recommend you contact your hospital consignees to check for hemolysis in their inventory of filtered Whole Blood and Red Blood Cells and to be vigilant in their routine examination of product immediately prior to release for transfusion. If hemolysis is found, ask your consignees to not use the product; and to notify you so that you can report to Pall as instructed 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, 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 (# units hemolyzed / # units inspected or processed)
- Age of the product at time of filtration
- From the original product container: the manufacturer and the anticoagulant/additive solution