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

Model Number 250D2

Device Problem Infusion or Flow Problem (2964)

Patient Problem Missed Dose (2561)

Event Date 09/28/2018

Event Type  malfunction  

Manufacturer Narrative

This event has been recorded in leventon (b)(4) as a customer complaint (reference (b)(4)), once the report mw5080251 was received from the distributor.According to this report, the defective unit was returned to manufacturer on 09/28/2018, but to date it has not been received in leventon (b)(4).Four (4) units from the same manufacturing lot were retrieved from retained samples and successfully passed flowrate testing.In addition, the batch records of the affected lot number were reviewed and no incidence similar to the one reported was detected in the controls done during the manufacturing process nor in the controls done before the product release.Therefore, it was not possible to determine the root cause of the defect reported.

Event Description

Grifols dosi-fuser 46 hour pump failed to infuse medication in required time.Contact 5-fu.

• 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: 8098894
• MDR Text Key: 129348543
• Report Number: 9611707-2018-00051
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 08436020760082
• UDI-Public: 08436020760082
• Combination Product (y/n): Y
• PMA/PMN Number: K040752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 09/28/2018

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: Health Professional
• Device Expiration Date: 04/27/2020
• Device Model Number: 250D2
• Device Catalogue Number: L25915-250D2-USA
• Device Lot Number: 180931L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 11/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other