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

Model Number 150D2

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

This event has been treated in leventon (b)(4) as an incidence ((b)(4)).According to the results obtained, the defect reported by the client is due to a random human error during the manual assembly of the pump.

Event Description

Defective dosi-fuser 150d2 pump.Prior to filling the pump, technician noted that "level indicator" has dislodged from the top of the balloon and was floating freely within the container.This could pose a problem in determining if a patient's infusion has completed.

• 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: 6982750
• MDR Text Key: 91107988
• Report Number: 9611707-2017-00002
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 08436020760068
• UDI-Public: 08436020760068
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/24/2019
• Device Model Number: 150D2
• Device Catalogue Number: L25915-150D2-USA
• Device Lot Number: 170658L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1