MAUDE Adverse Event Report: LEVENION DOSI-FUSER

Model Number 25915-100D2

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2015

Event Type  malfunction  

Event Description

Dosi-fuer did not dispense total dose of medication.Patient states noticed balloon was not going down after 1st day of 2 day treatment.Strength: 100ml/2day, dates of use: (b)(6) 2015.

• Brand Name: DOSI-FUSER
• Type of Device: DOSI-FUSER
• Manufacturer (Section D): LEVENION; barcelona, es
• MDR Report Key: 5319753
• MDR Text Key: 34251628
• Report Number: MW5058660
• Device Sequence Number: 1
• Product Code: MEB
• 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: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 25915-100D2
• Device Catalogue Number: 25915-100D2
• Device Lot Number: 150347L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 103