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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded in leventon (b)(4).As a customer complaint ((b)(4)).One month after receiving the complaint, the defective unit was not received and thus, the quality team proceeded with the complaint evaluation.As the unit related to this complaint was not available, an exhaustive evaluation of the reported defect was not possible and only the units from the archives of samples were 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, it was not possible to determine the root cause of the defect reported.
Event or Problem Description
In 5-fu medication scheduled for 46 hours, infusion time finished much earlier than expected.Patient was scheduled at 15.10 (approx.) for 5-fu takedown.Patient called and stated that her infusor was finished at 08.30.At 10.10, a nurse arrived and inspected the infusor.As per nurse observation, the infusor was completed.The chemo infusion finished for about 6 ½ hours earlier than the expected time (the accuracy of the infusion time is +/- 10%).In addition, patient stated that "this happens all the time, i am not new to this device and it's always 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: 7877857
• Report Number: 9611707-2018-00025
• Device Sequence Number: 2218172
• 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: other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 02/02/2018

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: Lay User/Patient
• Device Expiration Date: 11/10/2019
• Device Model Number: 250D2
• Device Catalogue Number: L25915-250D2-USA
• Device Lot Number: 172177L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1