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

Model Number	250D2
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been treated in (b)(4)).As stated several events in maude database are related to this complaint (in particular, mw5075505, mw5075507, mw5075508, mw5075509 and mw5075510).As it was not possible to determine the flow rate of 2 of the reported units, and since both the remaining reported unit and the units from the archives of samples were free of defects, it was not possible to determine the root cause of the defect reported.The defect reported was not detected, therefore the batch is correct.
Event or Problem Description
In 5-fu medication scheduled for 46 hours, patients reported that infusion time finished 2-10 hours earlier.Five patients experienced the same problem.

• Brand Name: DOSI-FUSER
• Common Device Name: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): LEVENTON S.A.U.; newton, 18-24; sant esteve sesrovires, barcelona 08635 ; SP 08635
• MDR Report Key: 7537070
• Report Number: 9611707-2018-00004
• Device Sequence Number: 10804939
• Product Code: MEB
• UDI-Device Identifier: 08436020760082
• UDI-Public: 08436020760082
• Combination Product (Y/N): Y
• PMA/510(K) Number: K040752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/15/2019
• Device Model Number: 250D2
• Device Catalogue Number: L25915-250D2-USA
• Device Lot Number: 172184L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1