Additional information: d10, e2, g2 (report source).Investigation conclusion: the report of an underinfusion was confirmed through both functional testing and review of the pcu event log.The pcu event log shows pump module s/n (b)(6) was in use and infusing (drugid 355) at a rate of 36.4ml/hr.At 10:50 pm on (b)(6) 2021, the user changed the vtbi to 200ml and then started the infusion.The infusion ran until 4:19 am when the primary infusion completed.At 4:29 am, the device was channeled off.The volume recorded as being infused during this period was 203.21ml.A review of the device error logs found no errors during the time of the reported event.The description stated that the intended programming was 2000mg/250ml, which would be a concentration of 8mg/ml and at this concentration, the rate would have been 45.5l/hr, 9.1ml/hr more than the actual 36.4ml/hr.Functional testing performed found the pump module to be delivering fluid out of specification on the low side.The cause of the accuracy error was determined to be the result of wear over time due to a misassembled camshaft.Device inspection: pump module s/n (b)(6) was received with instrument seal missing.The right (male) iui was observed with damaged isolation ribs and corrosion.The left (female) iui was observed to be in good condition.Platen assembly, post, hinge, pins, springs, and buttons are all intact and did not interfere with the door operation.Latch sear was installed properly and did not interfere with the door operation.Dried fluid residue was observed around the pivot latch spring.The platen and ail assembly were observed with dry fluid residue.All possible replacement parts were observed to be bd parts.Internal inspection of the returned device found dried fluid residue on the rear case facing iui connectors.One of the logic boards black plastic rivet was broken.The motor strap had faint stripes.One of the rear cases bottom screw was missing a washer.Wear was observed to the upper bezel shoulder due to friction from the upper bearing due to a misaligned camshaft.The incident administration set was not returned and could not be inspected.Root cause analysis: the root cause of the reported underinfusion was identified as due to both user programming and the device requiring calibration due to a misassembled camshaft.Device history review: a review of the device history record showed the device had a manufacture date of 05apr2007.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for pump module s/n (b)(6) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record was performed for the pump module s/n (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.
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The investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Patient information: the propofol was restarted.The patient was trached on (b)(6) and a peg tube was placed on (b)(6) for admitting diagnosis of: chf, resp failure, failure to wean.
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