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

Model Number	L25915-150D2-USA
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Infusion or Flow Problem (2964)
Health Effect - Clinical Codes	Toxicity (2333); Injury (2348)
Date of Event	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event has been treated in (b)(6).According to the results obtained in the testing, it can be concluded that the reported pump performed according to specifications and there is nothing that suggests an overinfusion because of a malfunction of the infusion pump if it is used as stated in the instructions for use there are some conditions that can affect the performance of the pump.The conditions are described below: balloon should be filled to nominal capacity with the medication to be infused.Temperature of the solution in the container should be at 22 ºc.Temperature of the capillary element should be 32 ºc, equivalent to its temperature when in contact with the skin.Capillary tube should be straight (i.E.Not twisted).The container should be worn according to the indications given in the instructions for use.There are other factors that can also affect the infusion time of the pump.These factors are described in the warning section of the instructions for use.
Event or Problem Description
Patient is being treated for colon cancer.Reporting (b)(6) for folfox adjunct chemo and for attachment of his 5-fu pump which should infuse over about 48 hours.The patient called early in the morning of (b)(6), stating his pump was empty and had been empty since about 6:30 the evening before.The patient was asked to come in and was admitted for possible 5-fu toxicity.He is doing very well and is getting the antidote as an inpatient.This was a conservative measure since the patient was on the borderline for safe administration of the drug.The patient was using a dosi-fuser pump which works by pressure and viscosity.

• Brand Name: DOSI-FUSER
• Common Device Name: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): LEVENTON S.A.U.; newton 18 - 24; sant esteve sesrovires, barcelona 08635 ; SP 08635
• MDR Report Key: 6967923
• Report Number: 9611707-2017-00001
• Device Sequence Number: 11087939
• Product Code: MEB
• UDI-Device Identifier: 08436020760068
• UDI-Public: 08436020760068
• Combination Product (Y/N): Y
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K040752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2019
• Device Model Number: L25915-150D2-USA
• Device Lot Number: 170500L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 10/23/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention