Miltenyi biotec was informed about the incident by the (b)(6).Until now it was not possible to obtain further information from the initial reporter, despite several attempts.Based on the provided information: "stammzellbeutel beim auftauen defekt." it can only be assumed that a cryomacs freezing bag was broken or leaked after thawing.Based on the fact that the incident was reported, it is likely that the material was lost due to the incident.It remains unknown if or how a patient was affected.Typically backup material is available for treatment.With the information available no investigation is possible.Complaints for the lot have been reviewed and the incident rate is very low with (b)(4).
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