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

Model Number 100D2

Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2017

Event Type  malfunction  

Manufacturer Narrative

This event has been treated in leventon (b)(4) as the defective unit was not available for inspection and the units from the archives of samples were free of defects, it was not possible to determine the root cause of the claimed defect.

Event Description

Patient started 5-fu continuous infusion as part of folfox chemotherapy regimen to be delivered via dosi-fuser.(total volume 86.3 ml; 100 ml/2 day/1.9 ml per hour).Patient observed in oncology clinic with malfunctioned pump.Lnner balloon had burst at some point (patient not able to determine when) and drug moving freely through chamber, drug not delivered to patient.Ndc: 100 ml 2 day pump 1.

• 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: 7547869
• MDR Text Key: 109368141
• Report Number: 9611707-2018-00010
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 08436020763861
• UDI-Public: 08436020763861
• 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: 07/14/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2017
• Device Model Number: 100D2
• Device Catalogue Number: L25915-100D2-USA
• Device Lot Number: 151963L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1