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 Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been treated in (b)(4).As the defective unit was not available for inspection and in the units from the archives of samples the defect reported by the customer was not found, it was not possible to determine the root cause of the claimed defect.
Event or Problem Description
Dosi-fuser elastomeric ambulatory pump leaked during 46 hr infusion and was reported today this morning, the day it was to be disconnected.A small portion of fluid (fluorouracil and normal saline) was detected on patient's nightshirt this morning at the home.It appeared the leak was associated with the seam around the "slo-flow" capillary element.White crystal accumulation around the seam of the capillary element was clearly visible by rn and pharmacy staff.

• 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: 7543936
• Report Number: 9611707-2018-00008
• Device Sequence Number: 178763
• 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): 11/16/2017

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: 02/23/2019
• Device Model Number: 250D2
• Device Catalogue Number: L25915-250D2-USA
• Device Lot Number: 170445L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 05/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1