MAUDE Adverse Event Report: SMITHS MEDICAL LEVEL 1 RAPID INFUSER; FAST FLOW FLUID WARMER

Device Problems Burst Container or Vessel (1074); Failure to Deliver (2338)

Patient Problem No Information (3190)

Event Date 03/17/2018

Event Type  malfunction  

Event Description

Difficulty with a level i rapid blood infuser that was used during a code.First unit exploded.Second unit transfused appropriately.Third unit stopped.Transfuser taken out of service.No serial number obtained.

• Brand Name: LEVEL 1 RAPID INFUSER
• Type of Device: FAST FLOW FLUID WARMER
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 7446330
• MDR Text Key: 106247065
• Report Number: MW5076568
• Device Sequence Number: 1
• Product Code: BSB
• 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: 04/17/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• 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 Age: 70 YR
• Patient Weight: 109