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

Model Number L25915-250D2-USA

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

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

Event Date 01/23/2015

Event Type  Injury  

Manufacturer Narrative

This event has been treated in (b)(6) as an incidence ((b)(4)), by checking the reserve samples of the involved lot number.The related internal report with conclusions is attached.

Event Description

Piloting new elastomeric pump dosi-fuser manufactured by leventon.Received incorrect product from distribution due the all labeled packaging/pump for 2 day pump are color labeled orange.Ordered 150 ml 2.8 ml/hr pump; however distribution center sent 250 ml 4.7 ml/hr pump.Received two boxes for the 250 ml size.Pilot and center caught the error brought to rep's awareness and distribution center sent correct product orange labeled 150 ml 2.8 ml/hr pump.Error occurred three days later (during pilot phase) when tech grabbed 250 ml 4.7 ml/hr pump instead of 150 ml 2.8 ml/hr pump and filled with chemotherapy fluorouracil and pharmacist checked product.Staff was not aware that pilot site had two sizes in stock as distribution did not want (b)(6) site to return 250 ml size pump.Due to pump looking exactly the same with orange labeling and staff not aware that two sizes were in stock, pt received incorrect product which lead to pump infusion in 29 hours instead of 46 hours.

• Brand Name: DOSI-FUSER
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): LEVENTON S.A.U.; esteve sesrovires, barcelona ; SP
• Manufacturer Contact: david salvatierra, qlty mgr ; c/newton 18-24, poligono; industrial sesrovires, sant; esteve sesrovires, barcelona 08635 ; SP 08635 ; 38176300
• MDR Report Key: 4975974
• MDR Text Key: 22380706
• Report Number: 9611707-2015-00004
• 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: other
• Remedial Action: Inspection
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: L25915-250D2-USA
• Device Catalogue Number: L25915-250D2-USA
• Device Lot Number: 141727L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1