About Particulate Matter
in Blood Bags
Recently, 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 a leading multinational Blood Bag Manufacturer.
The preliminary reports to FDA indicate that some particles are
consistent with platelet clumps.
FDA has also 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. Adverse
events in the transfusion setting can occur for many reasons,
including reasons related to and unrelated to the transfusion.
The procedures for examining liquid blood components for
particulate matter 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 has reminded blood establishments (both blood bag
manufacturing and blood banking) of the need to have and follow
appropriate visual inspection procedures for all blood and blood
(Ref : http://www.fda.gov/cber/infosheets/alertprtbld.htm)
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