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	07/07/2017
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 the units from the archives of samples were free of defects, it was not possible to determine the root cause of the claimed defect.
Event or Problem Description
Pt had leventon pump attached and returned 46 hours later for pump detachment.It was noted to have about 1-2 ml of loose liquid in the pump.No obvious signs of leaking from the pump and balloon was deflated indicating pump was empty.Pt denied any problems with leaking from the pump and did not notice any liquid in the pump while at home and states it must have happened the morning of scheduled detachment.Pump was disconnected and stored and is waiting to be sent to manufacturer for investigation.

• 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: 7547871
• Report Number: 9611707-2018-00011
• Device Sequence Number: 1862948
• Product Code: MEB
• UDI-Device Identifier: 08436020760082
• UDI-Public: 08436020760082
• 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): 07/10/2017

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: 02/27/2019
• Device Model Number: 250D2
• Device Catalogue Number: L25915-250D2-USA
• Device Lot Number: 170391L
• 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: 04/17/2018
• 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