The American Red Cross (ARC) has reported finding multiple units of blood and blood components that contain white particulate matter in a small percentage of blood bags manufactured by Baxter Healthcare Corporation. The exact nature of the material is not yet known, though preliminary reports to FDA indicate that some particles are consistent with platelet clumps. While this problem has been reported primarily in multiple lots of Baxter blood collection bags with a sampling port (PL-146), FDA has received additional preliminary reports involving other types and other manufacturers' blood bags and cannot rule out the possibility of similar findings with other bags. It is unclear at this time whether all reported observations are identical, whether all represent definite abnormalities, or whether there have been any resulting adverse health events due to the affected blood.
FDA has received a small number of adverse event reports in patients who received transfusions utilizing such bags, including one fatality that occurred in a severely ill patient. It is not yet clear whether the events are related to or unrelated to the possible presence of particulates. These reports are under investigation. Adverse events in the transfusion setting can occur for many reasons, including reasons related to and unrelated to the transfusion. FDA has no indications of a heightened risk of adverse events related to transfusions at this time.
ARC has implemented additional and specialized visual inspection procedures for examining liquid blood components for particulate matter. The procedures are performed prior to leukoreduction and at the time of packing for distribution. They include placing the bag, label down, on a flat counter undisturbed for 10 minutes and then performing a visual examination for particles.
FDA's regulations already call for visual inspection of blood and blood components (21 CFR 606.160(b)(3)(ii), 640.5(e)). Because of this recent event, we are reminding blood establishments of the need to have and follow appropriate visual inspection procedures for all blood and blood components. At this time, while evidence is limited, FDA considers the procedures mentioned above to be appropriate as an interim precautionary measure. FDA plans to issue guidance to blood establishments (including hospitals and clinics) shortly on these and any other appropriate visual inspection procedures.
If a blood establishment detects particles in blood or blood components, it should quarantine the affected products. You may report your findings expeditiously to FDA at the following e-mail address: BP_Deviations@cber.fda.gov, or by phone at 800-835-4709. FDA also will monitor this e-mail address and phone number for reports of adverse events potentially related to the presence of particulate matter.
FDA and CDC are continuing in-depth investigations. These investigations include examination of both blood bag manufacturing and blood banking practices as well as testing of these products.
FDA is issuing this alert and is planning guidance as a precautionary measure. For patients who need blood, the benefits of transfusion continue to outweigh the risks. The Agency will continue to update the blood industry and the public as additional information becomes available. FDA will take additional actions as needed based on evolving information to protect the safety of the blood supply.
Blood donors serve an important public health role in our country. Blood donation is a safe procedure and continued donations are critical to maintaining a safe and adequate blood supply.