Medtronic Inc. is recalling 2,543 units of the SynchroMed Model A10 drug infusion system due to a software display error. In software version 1.1.300, a decimal separator (a comma) is missing from the parameter range guidance values shown on several critical programming screens, including those for Infusion, Bolus, and Reservoir. This defect could cause a healthcare provider to misinterpret the recommended range for medication delivery, potentially leading to incorrect programming of the pump and errors in the dosage administered to the patient.
The missing decimal separator in range guidance values could lead to the programming of incorrect drug delivery rates or dosages. This poses a risk of medication overdose or under-infusion, which can have serious medical consequences depending on the medication being delivered.
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Sources: FDA iRES · Raw API Response
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