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

Model Number	100D2
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been treated in leventon (b)(4).However, it was not possible to assess the complaint.Unfortunately, the defective unit was not kept for inspection and the lot number was not given by the client.Therefore, the evaluation of the detected defect was not possible.
Event or Problem Description
Patient's chemotherapy ordered for 3750 mg to infuse over 46 hours using a dosi-fuser 100 at 1.9 ml/hr.Patient was seen to have infuser discontinued and it was noted it had not infused completely.The patient's port was flushed without difficulty and the infuser was reconnected.The patient returned the next day and the infuser was reconnected.The patient returned the next day and the infuser remained half full.The port was flushed again without difficulty.

• 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: 7540766
• Report Number: 9611707-2018-00007
• Device Sequence Number: 19307632
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/25/2017

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 Model Number: 100D2
• Device Catalogue Number: L25915-100D2-USA
• Device Lot Number: UNK.
• 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