Investigation: the run data file (rdf) was analyzed for this event.The trima accel system uses the entered donor information to ensure that the targeted products can be safely and efficiently collected within the trima accel safety box.If incorrect donor information is entered into the system, the system could collect products that are outside these limits, particularly maximum donation volume, minimum post-donation platelet count, minimum post-donation hematocrit and maximum ac infusion rate.Based on the available information, the entered weight of 220 lbs (tbv: 6,253 ml), when compared to the donor¿s actual weight of 218 lbs (tbv:6,223 ml), did not likely exceed any of these safety limits.Investigation is in process.A follow-up report will be provided.
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Investigation: entering in a donor weight of (b)(6) lb instead of the actual weight of (b)(6) lbs will result in a shift of the final fluid balance and in this case, it was calculated to be (b)(4)%.Therefore the data entry error did not result in an over depletion of greater than (b)(4)% of tbv.The customer acknowledged the investigative results of this event, including the risks associated with inputting an incorrect donor weight.Root cause: user interface issue.The operator entered the incorrect weight of donor.
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