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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEVENTON S.A.U. DOSI-FUSER; ELASTOMERIC INFUSION PUMP
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LEVENTON S.A.U. DOSI-FUSER; ELASTOMERIC INFUSION PUMP Back to Search Results
Model Number 250D2
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This event has been treated in (b)(6).As the defective units were not available for inspection 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
Two incidents were reported regarding 5-fu using dosi-fuser.In both cases; the chemo was found to be leaking through the dosi-fuser.These incidences did not reach the designated patients as they were discovered by the infusion nurse at the clinic prior to administration.
 
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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 Key7752552
Report Number9611707-2018-00019
Device Sequence Number1567100
Product Code MEB
UDI-Device Identifier08436020760082
UDI-Public08436020760082
Combination Product (Y/N)Y
PMA/510(K) Number
K040752
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Pharmacist
Type of Report Initial
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 Lay User/Patient
Device Expiration Date01/11/2020
Device Model Number250D2
Device Catalogue NumberL25915-250D2-USA
Device Lot Number180174L, 180459L
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2018
Initial Report FDA Received Date08/06/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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