• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LEVENTON S.A.U. DOSI-FUSER; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Device Problem Free or Unrestricted Flow (2945)
Patient Problem Overdose (1988)
Event Date 05/16/2018
Event Type  malfunction  
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 rn reporting that the dosi-fuser had completed the entire infusion 24 hours early.The correct infusion period should have been from monday at 1 pm until wednesday at 1 pm.The patient reported that the dosi-fuser completed on tuesday at about 1 pm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DOSI-FUSER
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
LEVENTON S.A.U.
14500 fm 470
tarpley TX 78883
MDR Report Key7925858
MDR Text Key122353511
Report Number7925858
Device Sequence Number1
Product Code MEB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/31/2018
Event Location Home
Date Report to Manufacturer10/02/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age28470 DA
-
-