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U.S. Department of Health and Human Services

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

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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 03/02/2018
Event Type  malfunction  
Event Description
Pt was connected to dosi-fuser at 1250.Pt came to clinic a few days later for disconnect and stated that his pump was complete when he woke at 7 am.
 
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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 Key7925854
MDR Text Key122353680
Report Number7925854
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
Was Device Available for Evaluation? No
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
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