MAUDE Adverse Event Report: LEVENTON S.A.U. DOSI-FUSER; ELASTOMERIC INFUSION PUMP

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.

• Brand Name: DOSI-FUSER
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): LEVENTON S.A.U.; c/ newton 18-24; sant esteve sesrovires, barcelona 08635 ; SP 08635
• Manufacturer (Section G): LEVENTON S.A.U.; c/ newton 18-24; sant esteve sesrovires, barcelona 08635 ; SP 08635
• Manufacturer Contact: mr. salvatierra ; c/ newton 18-24; sant esteve sesrovires, barcelona 08635 ; SP 08635
• MDR Report Key: 9364010
• MDR Text Key: 204998094
• Report Number: 9611707-2018-00056
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• PMA/PMN Number: K040752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 05/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/20/2020
• Device Catalogue Number: L2590260-US5300
• Device Lot Number: 181892L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1