Catalog Number L2590260-US5300 |
Device Problem
Insufficient Flow or Under Infusion (2182)
|
Patient Problem
No Information (3190)
|
Event Date 03/01/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
This event has been recorded by the manufacturer under customer complaint ref.(b)(4).As the unit related to this complaint was not provided for inspection, an exhaustive evaluation of the reported defect was not possible and only the units from the archives of samples were evaluated.Five units of the same lot number as the reported one kept at leventon's archives of samples were sent to a flow stability test.All the values observed on all units were within specifications.The batch record of the affected lot number has been reviewed and no incidence similar to the one reported was detected in the controls done during the manufacturing process nor in the control done before the release of this product.We have not been able to reproduce the defect detected by the customer according to the values obtained in the stability test and there was nothing that justifies an incidence as was reported by the client.So we are not been able to identify the root cause of the problem.
|
|
Event Description
|
As reported by user facility: during testing, the regulator was set at 250 so that the fluid would infuse in four hours.The bag was completely dry after two hours and sixteen minutes.No patient involvement.
|
|
Search Alerts/Recalls
|