MAUDE Adverse Event Report: BELMONT BELMONT RAPID INFUSER

Device Problems Failure to Prime (1492); Difficult to Open or Close (2921)

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

Event Date 07/07/2018

Event Type  Injury  

Event Description

Belmont rapid infuser stopped working properly and kept attempting to prime over and over again and would not prime tubing.Staff attempted troubleshooting to correct problem to no avail.The mechanical clamp would not open manually and prevented mass transfusion of blood product.Non-belmont rapid infuser was then utilized for patient care.

• Brand Name: BELMONT RAPID INFUSER
• Type of Device: RAPID INFUSER
• Manufacturer (Section D): BELMONT
• MDR Report Key: 7705789
• MDR Text Key: 114713251
• Report Number: MW5078485
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 69