It was reported that a ce intermate lv (large volume) did not infuse at all during a patient infusion.The device was filled with 1g methylprednisolone (solumedrol, non-baxter) and 250ml "g5%" (glucose, non-baxter).There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
H4: device manufactured between october 1, 2019 to october 2, 2019.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
|