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

Model Number	150D2
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).As the defect reported was not observed in the defective unit and the units from the archives of samples were free of defects, it was not possible to determine the root cause of the claimed defect.
Event or Problem Description
Patient presented for 5-fu infuser pump disconnection.Patient reported he noticed the pump was leaking shortly before presenting for the appointment.Upon inspection, the pump and medication carrier did have white residue and the pump appeared empty.The patient was exposed to chemo via the skin and clothing.No adverse events have been reported by the patient due to exposure.The leaking appears to have occured where the drug is added to the infuser.The manufacturer is sending a return package to do a full evaluation of the pump.

• 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: 7057132
• Report Number: 9611707-2017-00003
• Device Sequence Number: 19028154
• Product Code: MEB
• UDI-Device Identifier: 08436020760068
• UDI-Public: 08436020760068
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/23/2017

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: Health Professional
• Device Expiration Date: 06/12/2019
• Device Model Number: 150D2
• Device Catalogue Number: L25915-150D2-USA
• Device Lot Number: 171224L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2017
• 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: 11/23/2017
• Patient Sequence Number: 1
• Patient Age: 67 YR