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

Model Number L25915-250D2-FDA

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

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

Event Date 01/06/2016

Event Type  malfunction  

Manufacturer Narrative

This event has been treated in (b)(6).As an incidence (internal code for customer complaint: (b)(4)).It must be taken into account that the capillary element may deteriorate if placed in contact with solvents, as stated in the instructions for use.In this case, we consider that the capillary has been cleaned with a solvent which caused a deformation of the piece that can generate a leakage.The material of the body of the dosi-fuser is abs.The use of organic solvents such as alcohol can cause in plastic materials, such as abs and polycarbonate, fissures in the material structure like the crack in the capillary cover.These fisures may have been caused due to the cleaning of the capillary element with alcohol before connecting it to the patient.This defect is known as environmental stress cracking due to an external factor that causes a change in the material nature.After this issue, an inservice was provided to hospital in order to properly train the health personnel.

Event Description

Veteran started on fluorouracil continuous infusion with leventon dosi-fuser pump at 13.15.The patient returned to clinic at 14.55 indicating pump was leaking.Veteran indicated he had to change his shirt due to it being very wet from chemotherapy.Upon inspection of elastomeric device, it was leaking from capillary element.

• Brand Name: DOSI-FUSER
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): LEVENTON S.A.U.; newton, 18-24; sant esteve sesrovires, barcelona, spain 08635 ; SP 08635
• Manufacturer Contact: david salvatierra ; newton 18-24; sant esteve sesrovires, barcelona, spain 08635 ; SP 08635 ; 93 8176300
• MDR Report Key: 5687595
• MDR Text Key: 46163303
• Report Number: 9611707-2016-00003
• 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: distributor
• Reporter Occupation: Pharmacist
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: L25915-250D2-FDA
• Device Catalogue Number: L25915-250D2-FDA
• Device Lot Number: 151983L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1