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 treated in (b)(6).According to the results obtained, it seems that the defect might be due to the injection process of the capillary element.To investigate this, a corrective action has 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.[health_hazard_evaluation - dosi-fuser 2017.Pdf].
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: 7376692
• Report Number: 9611707-2017-00004
• Device Sequence Number: 1097574
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/22/2018

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: Other Health Care Professional
• 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2017
• Initial Report FDA Received Date: 03/28/2018
• Patient Sequence Number: 1