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	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been treated in (b)(4).As the defective unit was not available for inspection and the units from the archives of samples were used in previous tests, it was not possible to determine the root cause of the claimed defect.The defect reported was not detected, therefore the batch is correct.
Event or Problem Description
Patient was scheduled on (b)(6) 2018 at 15.10 (approximation) for 5fu 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 indeed complete.Based on the difference of the scheduled time and patient's called, the chemo infusion finished for about 6 ½ hours earlier than the expected time.In addition, patient stated that "this happens all the time, i'm 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: 7536200
• Report Number: 9611707-2018-00003
• Device Sequence Number: 11187051
• 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,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/23/2018

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2018
• Initial Report FDA Received Date: 05/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1