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

Model Number UNK.

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Information (3190)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded in (b)(4) as a customer complaint (reference (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 reported defect was not possible.

Event Description

Patient was connected to a dosi-fuser home pump containing fluorouracil on monday.The office received a phone call from a home care reporting that the dosi-fuser had completed the entire infusion 24 hours early.The correct infusion period should have been from monday at 1pm until wednesday at 1pm.The patient reported that the dosi-fuser completed on tuesday at about 1pm.

• Brand Name: DOSI-FUSER
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): LEVENTON S.A.U.; newton, 18-24; sant esteve sesrovires, barcelona 08635 ; SP 08635
• Manufacturer (Section G): LEVENTON S.A.U.; newton, 18-24; sant esteve sesrovires, barcelona 08635 ; SP 08635
• Manufacturer Contact: david salvatierra ; newton, 18-24; sant esteve sesrovires, barcelona 08635 ; SP 08635
• MDR Report Key: 8151256
• MDR Text Key: 130659419
• Report Number: 9611707-2018-00053
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• PMA/PMN Number: K040752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 08/31/2018

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
• Device Operator: No Information
• Device Model Number: UNK.
• Device Catalogue Number: UNK.
• Device Lot Number: UNK.
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1