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

Model Number	250D5
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been treated in leventon s.A.U.As an incidence ((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
250 ml/5 day pump was filled with 148.8 ml at 5fu and 31.2 ml of ns (normal saline) for a total volume of 180 ml for approximate 96 hours infusion time.Pump connected monday (b)(46) at 09.30 and should have run out on friday (b)(6) at approximately 08.00; but patient stated it was at "zero" on thursday (b)(6) at 17.00; approximately 15 hours early.

• 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: 7533137
• Report Number: 9611707-2018-00002
• Device Sequence Number: 169047
• Product Code: MEB
• UDI-Device Identifier: 08436020760020
• UDI-Public: 08436020760020
• 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: distributor
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/22/2018

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: No Information
• Device Expiration Date: 03/22/2019
• Device Model Number: 250D5
• Device Catalogue Number: L25915-250D5-USA
• Device Lot Number: 170508L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 05/22/2018
• Patient Sequence Number: 1