MAUDE Adverse Event Report: LEVENTON COMPANY DOSI-FUSER 5-FU

Model Number L25915-250D2

Device Problems Device Operates Differently Than Expected (2913); Improper Flow or Infusion (2954)

Patient Problem Swelling (2091)

Event Type  No Answer Provided  

Event Description

Seven incidents were reported regarding 5-fu using dosi-fuser from (b)(6) 2018 to (b)(6) 2018.The dosi-fuser was designed to deliver the 5-fu medication in 46 hours infusion.However, the infusion time was finished 2-10 hrs earlier than the scheduled.Per mfr, the accuracy of the infusion time is +- 10%.The lot numbers in question are lot #172184l (6 incidents), 172177l (1 incident).There are 6 pts experienced the same problem; (1 pt experienced the problem twice).On (b)(6) 2018, (b)(6) received 5-fu 3200mg and it was expected to finish around noon of (b)(6) 2018; however, the infusion finished 10 hrs early.Pt experienced adverse effects of face and tongue swelling that last for 2 days, but denies n/v/d.Ref # mw5075505, mw5075506, mw5075507, mw5075508, and mw5075509.

• Brand Name: DOSI-FUSER 5-FU
• Type of Device: DOSI-FUSER
• Manufacturer (Section D): LEVENTON COMPANY; 08635 sant esteve sesrovires; barcelona ; SP
• MDR Report Key: 7295910
• MDR Text Key: 101119462
• Report Number: MW5075510
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/15/2018
• Device Model Number: L25915-250D2
• Device Lot Number: 172184L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1