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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEVENTON S.A.U. (SPAIN) DOSI-FUSER; PUMP, INFUSION, ELASTOMERIC
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LEVENTON S.A.U. (SPAIN) DOSI-FUSER; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Model Number 250D2
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Diarrhea (1811); Nausea (1970); Overdose (1988); Confusion/ Disorientation (2553)
Event Date 08/14/2014
Event Type  malfunction  
Event Description
Patient left the infusion area twice with eis pump containing continuous infusion 5fu to run over 46 hours at home.The patient's daughter disconnects patient at home and claims that both infusions run in approximately 11 hours too fast.The patient experienced mental confusion, severe nausea and diarrhea.She had had 3 previous infusions that had gone fine.Daughter is an rn and states she is positive devices emptied both incidents.The dose administered too fast.This was not reported to the clinic or physician until patient came for return visit with physician two weeks later.At that time the patient was fine and not suffering any side effects.The decision in clinic was to switch patient to a gemstar pump.Patient was discharged from infusion with infusional 5 fu on a gemstar pump to infuse over 46 hours.
 
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Brand Name
DOSI-FUSER
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
LEVENTON S.A.U. (SPAIN)
14500 fm 470
tarpley TX 78883
MDR Report Key5017682
MDR Text Key23549844
Report Number5017682
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Report Date 06/25/2015,07/15/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2015
Is this an Adverse Event Report? Yes
Device Operator No Information
Device Model Number250D2
Device Lot Number140127L
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/25/2015
Event Location Hospital
Date Report to Manufacturer06/25/2015
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age84 YR
Patient Weight68
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