MAUDE Adverse Event Report: GRIFOLS / LEVENTON DOSI-FUSER

Model Number 150D2

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 08/28/2017

Event Type  malfunction  

Event Description

Detective dosi-fuser 150d2 pump; prior to filling the pump, tech noted that "level indicator" had dislodged from the top of the balloon and was floating freely within the container.This could pose a problem in determining if a pt's infusion had completed.

• Brand Name: DOSI-FUSER
• Type of Device: DOSI-FUSER
• Manufacturer (Section D): GRIFOLS / LEVENTON; los angeles CA 90032
• MDR Report Key: 6834497
• MDR Text Key: 84341210
• Report Number: MW5071881
• 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: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 150D2
• Device Lot Number: 170658L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• 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