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

Model Number	250D2
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded in leventon (b)(4) as a customer complaint ((b)(4)).The defective unit was not returned to manufacturer, thus the device was not evaluated.Six (6) units from the same manufacturing lot were retrieved from retained samples and successfully passed balloon filling testing (after 72 hours, none of the units showed the reported defect).In addition, the batch record of the affected lot number was reviewed and no incidence similar to the one reported was detected in the controls done during the manufacturing process nor in the controls done before the product release.Therefore, no problem was detected.
Event or Problem Description
Two incidents were reported regarding 5-fu using dosi-fuser.In both cases; the chemo was found to be leaking through the dosi-fuser.These incidences did not reach the designated patients as they were discovered by the infusion nurse at the clinic prior to administration.

• 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: 7901597
• Report Number: 9611707-2018-00036
• Device Sequence Number: 16531963
• 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

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: 01/11/2020
• Device Model Number: 250D2
• Device Catalogue Number: L25915-250D2-USA
• Device Lot Number: 180174L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1