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

Model Number UNK.

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Information (3190)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded in leventon (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 reported that dosi-fuser was not empty 4 hours past expected end time.Home care nurse removed dosi-fuser and instructed patient to return dosi-fuser to clinic.

• 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: 8156042
• MDR Text Key: 131377335
• Report Number: 9611707-2018-00055
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• 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: 12/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1