In 2004, a donor called the plasma center to report that approx 5 hour after their donation in 2004, they developed itching on their arms, legs and buttocks. The donor stated that the itching has continued. Center presonnel instructed the donor to increase their fluid intake and to take benadryl (dose unk). Additional info after the event revealed that the donation which occurred in 2004 was unremarkable. The donor left the plasma center facility in good condition after their donation. Donor was contacted by the center later in 2004 at which time the donor indicated that the benadryl had relieved the itching over the last two hours. No other complaints from the donor were experssed at the time of the follow-up call. The donor followed up with their physician in 2004. At that time the physician diagnosed the donor with pruritis and presrcibed benadryl (dose unk) and zyrtec (dose unk) for itching. The plasma center has deferred this donor from further apheresis donations.

A batch review was review was performed by baxter for lot a04a22024. Results of the batch review revealed that there were no manufacturing related issues seen during the manufacturing process for this batch lot number. All appropriate test results were found to be within specification requirements. Microbilogical test results were satisfctory. The sterilization dose applied was the appropriate amount according to the product specification. The complaint database was queried over a two-year interval for any reports of "hives" for this lot number and product code. No other reports of "hives" have been received by baxter for lot number a04a22024. A total of 3 reports of "hives" have been received by baxter for product code 4r2256 without any serious outcomes.