Reportedly, two freezing containers were found ruptured after transportation from another facility. The contents of the container, peripheral blood stem cells, were disposed of at the time of the events. The pt was not impacted by the event. Sufficient back up cells remained to transplant the pt. The containers will not be returned for eval. The containers, after removal from the liquid nitrogen storage tank are extremely fragile in this frozen state. Care must be taken when handling or transporting the frozen product not cause any mechanical damage to the plastic continer. Small cracks or fractures in the body of the container may cause the ingress of liquid nitrogen and casue the rupture or distention of the containers. Freezing and thawing recommendations are distributed with each model number sold.

Baxter healthcare corp ("baxter") submits the folowing report, together with any telephone or written reports on the same incident, to the fda pursuant to the provisions of 21 cfr part 803. These reports are based on info rec'd by baxter which baxter may not have had any opportunity to investigate or verify prior to the required reporting date. These reports shall not be construed as an admission by baxter that the product(s), described herein, are products of its mfr and are or were defective or dangerous products in any respect, or that any casual relationship exists between these products and any actual or potential injury. In addition, the submission of a report by baxter shall not be construed as an admission that a reportable event has in fact occurred.