Investigation: per the investigation, use of d5w (5% dextrose in water solution), instead of albumin/saline for replacement fluid, has the potential for inducing hyperglycemia in the patient.Per internal risk review, the residual total risk level is low for this event.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Correction: a terumo blood and cell technology specialist offered retraining to the customer on 08/04/2020.The customer declined training as they stated the known user error was recognized internally.Root cause: based on the clinical findings, the root cause of the use of an incorrect replacement fluid was operator error.
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The customer called because during a therapeutic plasma exchange (tpe) procedure on a myasthenia gravis patient using a spectra optia device, the customer realized d5w (dextrose solution) was hung as replacement fluid.Per the customer it is normal practice to for this customer to use a combination of saline and albumin for stable patients but in this case, the operator mistakenly hung d5w instead of saline.It was confirmed that the machine was not primed with d5w.The customer stated that only 6 mls of d5w had passed over the replacement pump.The terumo bct support specialist advised the customer to abort the procedure without rinseback.Per the customer the device was reset up and the patient was treated with a fresh set, with no further issues were reported.Per the customer the patient is stable with no consequences to patient.The disposable set is not available for return because it was discarded by the customer.
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