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

Model Number	150D2
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been treated in leventon s.A.U.As an incidence (internal code for customer complaint: (b)(4)).According to the results obtained, it seems that the defect might be due to the injection process of the capillary element.To investigate this, a corrective action has been opened to identify the root cause and solve the problem detected.In addition, a health hazard evaluation has been carried out, concluding that the patient risk is very low and therefore it is not considered necessary to perform any type of action on the lots that are on the market.
Event or Problem Description
The drug product has precipitated and damaged the capillary element of the dosi-fuser.The damage caused more drug to leak from the capillary element.

• 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: 7547425
• Report Number: 9611707-2018-00009
• Device Sequence Number: 2413406
• Product Code: MEB
• UDI-Device Identifier: 08436020760068
• UDI-Public: 08436020760068
• Combination Product (Y/N): N
• 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): 09/25/2017

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: Health Professional
• Device Expiration Date: 03/21/2019
• Device Model Number: 150D2
• Device Catalogue Number: L25915-150D2-USA
• Device Lot Number: 170500L
• 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: 05/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1