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

Model Number	250D2
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded in leventon (b)(4) as a customer complaint (reference (b)(4).The defective unit was not returned to the manufacturer, thus the device was not evaluated.Six (6) units from the same manufacturing lot were retrieved from retained samples and successfully passed flow rate testing.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
Dosi-fuser (grifols) is an elastomeric infuser that was implemented as a replacement for the cadd priszm pumps.Currently, we have approximately 5-10 patients per week that is using dosi-fuser.The typical regimen calls for the medication to be given over 46 hours.There is a standard deviation of plus/minus 10 percent variability for infusion time.Over a two-week period, 6 out of 14 patients experienced early completion of their infusions with the dosi-fuser, with completion times ranging from 5 hours to 9.5 hours ahead of schedule.With a planned infusion time of 46 hours, a standard deviation of plus/minus 10 percent would allow normal variation within 4.6 hours.Early completion times of 5 - 9.5 hours ahead of plan exceed the standard deviation.

• 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: 7896979
• Report Number: 9611707-2018-00031
• Device Sequence Number: 1449650
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2016

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: 05/31/2017
• Device Model Number: 250D2
• Device Catalogue Number: L25915-250D2-USA
• Device Lot Number: 150959L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1