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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 UNK.
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problem No Information (3190)
Event Date 05/16/2018
Event Type  malfunction  
Manufacturer Narrative
This event has been recorded in (b)(4) as a customer complaint (reference (b)(4).However, it was not possible to assess the complaint.Unfortunately, the defective unit was not kept for inspection and the lot number was not given by the client.Therefore, the evaluation of the reported defect was not possible.
 
Event Description
Patient was connected to a dosi-fuser home pump containing fluorouracil on monday.The office received a phone call from a home care reporting that the dosi-fuser had completed the entire infusion 24 hours early.The correct infusion period should have been from monday at 1pm until wednesday at 1pm.The patient reported that the dosi-fuser completed on tuesday at about 1pm.
 
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Brand Name
DOSI-FUSER
Type of Device
ELASTOMERIC INFUSION PUMP
Manufacturer (Section D)
LEVENTON S.A.U.
newton, 18-24
sant esteve sesrovires, barcelona 08635
SP  08635
Manufacturer (Section G)
LEVENTON S.A.U.
newton, 18-24
sant esteve sesrovires, barcelona 08635
SP   08635
Manufacturer Contact
david salvatierra
newton, 18-24
sant esteve sesrovires, barcelona 08635
SP   08635
MDR Report Key8151256
MDR Text Key130659419
Report Number9611707-2018-00053
Device Sequence Number1
Product Code MEB
Combination Product (y/n)Y
PMA/PMN Number
K040752
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial
Report Date 08/31/2018
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
Device Operator No Information
Device Model NumberUNK.
Device Catalogue NumberUNK.
Device Lot NumberUNK.
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/13/2018
Initial Date FDA Received12/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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