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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEVENTON DOSI-FUSER PUMP; DOSI-FUSER INFUSION PUMP
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LEVENTON DOSI-FUSER PUMP; DOSI-FUSER INFUSION PUMP Back to Search Results
Model Number L25915-150D2
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems Overdose (1988); Toxicity (2333)
Event Date 08/11/2017
Event Type  Injury  
Event Description
Pt is being treated for colon cancer.Reporting (b)(6) for folfox adjunct chemo and for attachment of his 5-fu pump which should infuse over about 48 hours.The pt called early in the morning of (b)(6)2017 stating his pump was empty and had been empty since about 6:30 the evening before.The pt was asked to come in and was admitted for possible 5-fu toxicity.He is doing very well and is getting the antidote as an inpatient.This was a conservative measure since the pt was on the borderline for safe administration of the drug.The pt was using a dosi-fuser pump which works by pressure and viscosity.
 
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Brand Name
DOSI-FUSER PUMP
Type of Device
DOSI-FUSER INFUSION PUMP
Manufacturer (Section D)
LEVENTON
c/ newton 18-24 sant esteve sesrovires
barcelona 08635
SP  08635
MDR Report Key6830656
MDR Text Key84107207
Report NumberMW5071848
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 Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberL25915-150D2
Device Lot Number170500
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/28/2017
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
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