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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEVENTON DOSI-FUSER; ELASTOMERIC INFUSION PUMP
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LEVENTON DOSI-FUSER; ELASTOMERIC INFUSION PUMP Back to Search Results
Model Number 25915-250D2
Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)
Patient Problem Chemical Exposure (2570)
Event Date 01/06/2015
Event Type  Injury  
Event Description
Upon attaching the leventon dosi-fuser 250d2 pump to the pt and releasing the clamp on the iv set, the pump leaked on to the pt's skin.The pump was detached from the pt, dried and visually checked by the nurse and physician in the clinic.The nurse reported seeing fluid leak directly from the thermal/flow regulator on the leventon dosifusor 250d2 iv line.The pump was placed in a ziplock chemotherapy bag and disposed of in a hazardous waste bucket.Diagnosis or reason for use: administer continuous infusion of fluorouracil over 46 hours.
 
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Brand Name
DOSI-FUSER
Type of Device
ELASTOMERIC INFUSION PUMP
Manufacturer (Section D)
LEVENTON
barcelona
SP 
MDR Report Key4412910
MDR Text Key18038518
Report NumberMW5040172
Device Sequence Number1
Product Code MEB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 01/07/2015
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 Health Professional
Device Expiration Date07/31/2016
Device Model Number25915-250D2
Device Lot Number141171L 0671
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/07/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
(DAY 1); LORAZEPAM 1 MG IV Q2WK, 30 MIN PRIOR TO CHEMO; RXN RIJ MEDIPORT FOR CHEMOTHERAPY INFUSION; DEXAMETHASONE 8 MG IV Q2WK, 30 MIN PRIOR TO CHEMO; (DAY 1); 1 Q2WK; IRINOTECAN 180 MG/M2 (400 MG) IV OVER 2 HRS; FOSAPREPITANT 150 MG IV Q2WK, 30 MIN PRIOR TO; HYOSCYAMINE 0.25 MG PO ONCE FOR ACUTE CHOLINERGIC; ONDANSETRON 16 MG IV Q2WK, 30 MIN PRIOR TO CHEMO; CHEMO (DAY 1); (DAY 1) Q2WK; 4 MIN (DAY 1) Q2WK; LEUCOVORIN 400 MG/M2 (880 MG) IV OVER 2 HRS; (DAY 1) Q2WK; FLUOROURACIL 400 MG/M2 (875 MG) IV BOLUS OVER; BEVACIZUMAB 5 MG/KG (475 MG) IV OVER 10 MIN DAY; (DAY 1)
Patient Outcome(s) Required Intervention;
Patient Age44 YR
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