MAUDE Adverse Event Report: LEVENTON S.A.U. DOSI-FUSER

Model Number L25915-250D2-USA

Device Problems Inaccurate Flow Rate (1249); Excess Flow or Over-Infusion (1311); Device Operates Differently Than Expected (2913)

Patient Problems Diarrhea (1811); Nausea (1970); Confusion/ Disorientation (2553)

Event Date 08/14/2014

Event Type  malfunction  

Manufacturer Narrative

This event has been treated in (b)(6).As an incidence ((b)(4)).We have been notified that one dosi-fuser unit had overinfusion during a 5-fu treatment on a patient, in the conditions and outcomes related in block b.5.The defective unit was not returned to us, therefore we can't perform an exhaustive evaluation on a patient, in the conditions and outcomes related.The defective unit was not returned to us, therefore we can't perform an exhaustive evaluation of the defect detected and we can't find out the possible causes of this product behavior.The batch record of the involved lot number was reviewed and no incidence similar to the reported one was detected in the controls done during the manufacturing process nor in the control done before product release.None of the evaluated units showed any kind of defect.Three retained units of the same lot number were tested, with positive results.Therefore, we have not been able to reproduce the defect detected by the customer.We consider that the defective unit could have been affected by some of the external factors that can modify the infusion time (temperature and viscosity of the solution, filling volume or height of reservoir with regard to the mid-auxilliary level).

Event Description

Patient left the infusion area twice with dosi-fuser containing continuous infusion of 5-fu to run over 46 hours at home.The patient's daughter disconnects patient at home and claims that both infusions run in approx.11 hours to fast.The patient experienced mental confusion, severe nausea and diarrhea.She had 3 previous infusions that had gone fine.Daughter is an rn and states she is positive devices emptied both incidents the dose administered too fast.This was not reported to the clinic or physician until patient came for return visit with physician 2 weeks later.At that time the patient was fine and not suffering any side effects.The decision in clinic was to switch patient to a gemstar pump.Patient was discharged from infusion with infusional 5-fu on a gemstar pump to infuse over 46 hours.

• Brand Name: DOSI-FUSER
• Manufacturer (Section D): LEVENTON S.A.U.; sant esteve sesrovires; barcelona ; SP
• Manufacturer Contact: david salvatierra, quality mgr. ; c/newton 18-24, poligono; industrial sesrovires, sant; barcelona ; SP ; 38176300
• MDR Report Key: 5098030
• MDR Text Key: 26605236
• Report Number: 9611707-2015-00005
• Device Sequence Number: 1
• Product Code: MEB
• 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: Other Health Care Professional
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/29/2016
• Device Model Number: L25915-250D2-USA
• Device Catalogue Number: L25915-250D2-USA
• Device Lot Number: 140127L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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
• Patient Age: 84 YR
• Patient Weight: 68