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

Model Number	100D2
Medical Device Problem Codes	Partial Blockage (1065); Loss of or Failure to Bond (1068); Failure to Infuse (2340)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the results obtained, the defect reported by the client is not observed.However, it could be due to a human error during the positioning of the stickers, therefore we understand that it is an isolated issue.
Event or Problem Description
Patient presented to clinic because her pump was no longer infusing medication.Label indicating volume and infusion rate provided by the manufacturer inside the pump capsule was bent and was impeding the level indicator.Contacted the mfr and they indicated that the pumps were recently upgraded putting so that the labels were now inside rather than outside the pump.Pump had to be disconnected and medication had to be put in a 24 hour pump.

• 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: 7539912
• Report Number: 9611707-2018-00005
• Device Sequence Number: 16502032
• Product Code: MEB
• UDI-Device Identifier: 08436020763861
• UDI-Public: 08436020763861
• 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): 07/19/2017

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: 01/10/2019
• Device Model Number: 100D2
• Device Catalogue Number: L25915-100D2-USA
• Device Lot Number: 170092L
• 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: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1