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

Catalog Number L25915-250D2-FDA

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

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

Event Date 06/21/2014

Event Type  malfunction  

Event Description

Patient reported that her chemo infusor was close to completion and was not due for disconnect until the following afternoon.Patient was connected to continuous infusion of 5f uchemo therapy via dosi-infusor.The infusor appeared to have completed 3/4 of infusion with approximately 18 to 20 hours before scheduled disconnect.Patient reported spending approximately 1 hour outside in the sun.Photos taken; notified md; discontinued infusion; port flushed and port needle d/c'd.Pt was stable with no signs or symptoms of adverse reaction.

Manufacturer Narrative

This event has been treated in leventon s.A.U.As an incidence (internal code (b)(4)).The client indicates that one chemo infusor was close to completion and was not due for disconnect until the following afternoon.Patient was connected to continuous infusion of 5fu chemo therapy via dosi-fuser.The infusor appeared to have completed 3/4 of infusion with approximately 18 to 20 hours before scheduled disconnect.But the defective unit was not sent by the client, and for this reasons we can't perform an exhaustive evaluation of the defect detected.We don't know the filling volume, the desired infusion time neither the exact amount of liquid not infused (the scale is not intended for measuring, it is only for checking the evolution of the infusion process).Therefore, we cannot find out the possible cause of the detected defect.The batch record of the affected lot number has been 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 the lot release.In addition, 4 samples of this lot were submitted to an infusion test, and none of them showed any kind of defects.So, all units are inside specifications.Therefore it is not possible to reproduce internally the defect reported by the customer.

• Brand Name: DOSI-FUSER
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): LEVENTON S.A.U.; sant esteve sesrovires, barcelona ; SP
• Manufacturer Contact: david salvatierra, (quality mgr ; c/newton 18-24,; pol. industrial sesrovires; sant esteve sesrovires, barcelona ; SP ; 38176300
• MDR Report Key: 4316737
• MDR Text Key: 5129016
• Report Number: 9611707-2014-00001
• 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
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2016
• Device Catalogue Number: L25915-250D2-FDA
• Device Lot Number: 140211L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2014
• 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 Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 61