Concomitant medical products: product id: a810, serial#: unknown, product type: software.Other relevant device(s) are: product id: a810, serial/lot #: unknown, ubd: unknown , udi#:unknown.If information is provided in the future, a supplemental report will be issued.
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Information was received from a consumer regarding a patient receiving intrathecal clonidine 200 mcg/ml at 83.99 mcg/day and hydromorphone 2.5 mg/ml at 1.0499 mg/day via an implanted pump.It was reported the patient had her pump refilled on (b)(6) 2020 and she was locked out from getting a bolus as a physician bolus was in progress.It was noted as a result, the patient was up all night and in a lot of pain.The patient checked her telemetry slip and it said 36 hours.The patient was going back into the hcp office right now to have them change this.Additional information was received from a healthcare provider (hcp) on the same day indicated the patient was at his clinic and would like to make adjustments so there were no boluses running.The hcp confirmed there were no changes to medication or concentration at yesterday's refill; therefore, there should not have been any bridge boluses programmed.The hcp was walked through steps to cancel current bridge bolus on the tablet so the patient could start using their ptm right away.No further complications were reported.
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