MAUDE Adverse Event Report: CSL BEHRING LLC FREEDOM 60 PUMP; INTRAVASCULAR ADMINISTRATION SET

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 08/17/2017

Event Type  malfunction  

Event Description

Pt's mom called stating that problem with the pump.She said syringe kept popping out of pump and infusion was too fast.They did finish the infusion.Rph asked if flow rate tubing connected, and mom said it was.Rph ok'd to have pump exchanged, but reminded mom to remember to keep flow rate tubing connected securely before infusing.Serial number unk.Pt is scheduled for a pump exchange and will be returning that pump, and no issues experienced by pt due to product problem.

• Brand Name: FREEDOM 60 PUMP
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): CSL BEHRING LLC
• MDR Report Key: 6830635
• MDR Text Key: 84108074
• Report Number: MW5071846
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14 YR