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

Model Number 250D5

Device Problem Burst Container or Vessel (1074)

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

Event Date 09/11/2015

Event Type  malfunction  

Manufacturer Narrative

This event has been treated in leventon (b)(4).As an incidence ((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.Note: the mw5056176 adverse event report states that the model is 250d2 (2-day infusion).This is not correct, since the lot number 131807l corresponds to a 250d5 model (5-day infusion).

Event Description

Leakage of chemotherapy solution (2-5 ml) from elastomeric balloon into pump capsule.Solution was contained within pump and did not leak outside of infusion device.

• 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: 7552689
• MDR Text Key: 109513712
• Report Number: 9611707-2018-00017
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 08436020764882
• UDI-Public: 08436020764882
• 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: 09/11/2015

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: 12/31/2015
• Device Model Number: 250D5
• Device Catalogue Number: L25915-250D5-FDA
• Device Lot Number: 131807L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2018
• Initial Date FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1