MAUDE Adverse Event Report: B. BRAUN EASY PUMP ELASTOMERIC INFUSION PUMP; PUMP, INFUSION, ELASTOMERIC

Device Problem Free or Unrestricted Flow (2945)

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

Event Date 07/12/2018

Event Type  malfunction  

Event Description

Received call from cancer center stating that the patient reported his easypump infusion device appeared empty 6 hours before the infusion was supposed to be completed.Infusion lasted 40 hours instead of 46 hours.

• Brand Name: EASY PUMP ELASTOMERIC INFUSION PUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN
• MDR Report Key: 7742399
• MDR Text Key: 116110182
• Report Number: MW5078772
• Device Sequence Number: 0
• 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: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2018
• 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
• Patient Age: 53 YR
• Patient Weight: 68