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	Swelling (2091)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded in (b)(6).Three (3) units were returned to our facility for testing.In two (2) of them, visual inspection failed and flow rate testing could not be performed because its capillary element was partially blocked (probably because of drug crystallization).The other returned unit passed visual inspections and standardized flow rate test.In addition, five (5) units from the same manufacturing lot were retrieved from retained samples and successfully passed visual inspection and flow rate testing.Therefore, as it was not possible to determine the flow rate of two (2) of the returned units, and since both the remaining returned 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.
Event or Problem Description
In 5-fu medication scheduled for 46 hours, infusion time finished much earlier than expected.Patient received 5-fu 3200mg and it was expected to finish around noon.However, the infusion finished 10 hours early (the accuracy of the infusion time is +/- 10%).Patient experienced adverse effects of face and tongue swelling that lasted 2 days, but denied nausea / vomiting / diarrhea.

• 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: 7877807
• Report Number: 9611707-2018-00024
• Device Sequence Number: 13949626
• 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: other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/02/2018

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: 02/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1