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

Model Number	250D2
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Missed Dose (2561)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded in leventon (b)(4) as a customer complaint (reference (b)(4)), once the report mw5080251 was received from the distributor.According to this report, the defective unit was returned to manufacturer on 09/28/2018, but to date it has not been received in leventon (b)(4).Four (4) units from the same manufacturing lot were retrieved from retained samples and successfully passed flowrate testing.In addition, the batch records of the affected lot number were 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, it was not possible to determine the root cause of the defect reported.
Event or Problem Description
Grifols dosi-fuser 46 hour pump failed to infuse medication in required time.Contact 5-fu.

• 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: 8098894
• Report Number: 9611707-2018-00051
• Device Sequence Number: 14018623
• Product Code: MEB
• UDI-Device Identifier: 08436020760082
• UDI-Public: 08436020760082
• 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: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 09/28/2018

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: Health Professional
• Device Expiration Date: 04/27/2020
• Device Model Number: 250D2
• Device Catalogue Number: L25915-250D2-USA
• Device Lot Number: 180931L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other