[2356842]
A platelet pheresis was distributed that had a documentation discrepancy in the sterile weld results. During the bact sampling process, for platelet bacterial contamination testing, the technician inadvertently opened the clamps prior to the weld cycle being completed. The trucise software that is connected to the sterile welder alerted with a clamp error. The trucise software prompted the technician to accept or reject the weld result. The technician rejected the weld and added the comment "clamp opened during weld. " the trucise software then asked the technician if the weld would be repeated yes or no. The technician selected yes and successfully completed the weld process and accepted the weld. However, the trucise weld report only captured the first "rejected" weld with the technicians comments. The second weld record is not included in the report. Upon discovery the consignee was contacted and the unit, that had not been issued, was quarantined and returned to arup blood services. The trucise vendor, terumo, was contacted. On (b)(6) 2011, a terumo representative informed arup blood services that the qa department was unable to reproduce this error. Terumo will be coming to services that the qa department was unable to reproduce this error. Terumo will be coming to arup blood services to download the event logs from our system for qa evaluation and further investigation. This error was also reported the cber as a biologic product deviation. (b)(4).
Patient Sequence No: 1, Text Type: D, B5