Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
Reason for recall: Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose. Distribution: Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA, PA, NY, CA, IA and the country of Philippines. Quantity: 1701 units Lot/code info: 1) 400020401: UDI/DI 400020401, Serial/Lot Numbers: 50000184; UDI/DI +M335400021, Serial/Lot Numbers: 50002748, 50002774, 50001647, 50001654, 50001601, 50001615, 50001651, 50002547, 50002577, 50002678, 50002689, 50002750, 50002751, 50002755, 50002773, 50002788, 50002798, 50002799, 50002801, 50002807, 50002808, 50002818, 50002819, 50002820, 50002821, 50002822, 50002823, 50002824, 50002825, 50002828, 50002832, 50002835, 50002837, 50002839, 50002840, 50002844, 50002845, 50002847, 50002851, 50002853, 50002858, 50002892, 50003000, 50003002, 50003009, 50003023, 50003026, 50003029, 50003033, 50003034, 50003035, 50003036, 50003039, 50003043, 50003045, 50003051, 50003054, 50003058, 50003059, 50003060, 50003062, 50003063, 50003065, 50003087, 50003092, 50003126, 50003143, 50003157, 50003167, 50003201, 50003232, 50003241, 50003244, 50003246, 50003257, 50003259, 50003260, 50003261, 50003262, 50003266, 50003267, 50003268, 50003269, 50003272, 50003274, 50003277, 50003278, 50003279, 50003280, 50003281, 50003282, 50003285, 50003286, 50003287, 50003288, 50003290, 50003291, 50003292, 50003293, 50003298, 50003299, 50003300, 50003301, 50003302, 50003305, 50003307, 50003308, 50003309, 50003311, 50003312, 50003316, 50003317, 50003319, 50003329, 50003331, 50003334, 50003335, 50003339, 50003340, 50003343, 50003345, 50003352, 50003360, 50003403, 50003415, 50003431, 50003433, 50003456, 50003460, 50003485, 50003492, 50003497, 50003498, 50003500, 50003514, 50003524, 50003548, 50003575, 50003603, 50003604
Official record: FDA (Device enforcement) ↗
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