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

Model Number	250D5
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded in leventon (b)(4) as a customer complaint (reference (b)(4)).The photograph sent by the customer on (b)(6) 2017 illustrating the reported defect was visually inspected and the presence of crystallized medication in the welding area of the capillary element was confirmed.Four (4) units from the same manufacturing lot were retrieved from retained samples, were visually inspected and were submitted to leaking testing.Two (2) of the four units showed leakages at the capillary element.In addition, the batch record of the affected lot number was 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.After that, on 01/09/2018 we received the defective unit from the customer, which showed crystallized medication around the welding area of the capillary element.It seems that the defect might be due to the injection process of the capillary element.Because of similar previous complaints, a corrective action had already been opened to identify the root cause and solve the problem detected.Likewise, a health hazard evaluation has been carried out, concluding that the patient risk is very low and therefore it is not considered necessary to perform any type of action on the lots that are on the market.
Event or Problem Description
Using leventon portable dosi-fuser lv 5.2 2.1 ml for outpatient chemo patients.Have had 4 incidents of the chemo leaking at the capillary sensor (taped to the skin of the patient), has leaked and caused the chemo to crystalize outside of the patient's body.Contacted the distributor, pulled and returned all catalog of product code #250d5 with lot #170101l (22 each) for qa by manufacturer.Portable chemo pump used in hematology oncology practice.

• 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: 7901270
• Report Number: 9611707-2018-00033
• Device Sequence Number: 13811552
• Product Code: MEB
• UDI-Device Identifier: 08436020760020
• UDI-Public: 08436020760020
• Combination Product (Y/N): N
• PMA/510(K) Number: K040752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2017

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
• Operator of Device: No Information
• Device Expiration Date: 01/16/2019
• Device Model Number: 250D5
• Device Catalogue Number: L25915-250D5-USA
• Device Lot Number: 170101L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other