This report has been identified as b.Braun medical internal report number (b)(4).The product involved in the reported incident was returned to one of our b.Braun facilities and the device was evaluated by a qualified technician during the investigation.When the pump was evaluated, the reported issue was not observed.Investigation results: delivery accuracy of 250ml/hr and 25ml tested in spec at 5 minutes 53 seconds or 102% of expected accuracy.Occlusion pressure and air sensor threshold measurements tested in spec.Log review shows on 11/10/2022 and 19:11pm an infusion start of 989ml/hr and 1000ml (dl: ns0.9%).4 pressure alarms occurred during infusion and at 20:15pm with a volume infused to 985.93ml, 2 air alarms occurred with no further infusions taking place that day.On 11/11/2022 and 11:40am an infusion start of 200ml/hr and 1000ml (dl: lr).An air alarm stopped the infusion with a volume infused to 0.42ml.Piggyback was selected and at 11:43am an infusion start of 12.5ml/hr and 4 hours (dl: magnes4).At 11:46am piggyback infusion was stopped with a piggyback volume infused of 0.58ml.No further infusions took place.
|