Investigation summary: an allegation related to pump failed to activate was reported.Product analysis concluded these activation issues could affect the functionality of the pump.Device technical analysis: the ams 700 momentary squeeze (ms) pump was visually inspected and functionally tested; no leaks were found.The pump was functionally tested and failed the 8lb.Activation test.The pump therefore required more than 8lbs.Of force to activate.Product analysis concluded these activation issues could affect the functionality of the pump.Product analysis confirmed pump malfunction.Device history record (dhr): review of manufacturing documentation was performed to ensure that all required in-process and final inspections and testing were completed.Review of the manufacturing records for batch 1000300231 found no evidence that the device failed to meet applicable product specifications prior to shipment from boston scientific.Labeling review: there is no objective evidence that the user did not properly handle or use the device according to the ifu, ams700 ms pump.Additionally, the reported events do not contain an allegation against the labeling.Conclusion: based on this investigation, the investigation conclusion code of cause traced to component failure was chosen because the reported events could be traced to a component failure.
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