MAUDE Adverse Event Report: BELMONT INSTRUMENTS BUDDY LITE FLUID WARMER

Catalog Number 905-00017

Device Problems Burst Container or Vessel (1074); Hole In Material (1293); Leak/Splash (1354)

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

Event Date 05/18/2015

Event Type  malfunction  

Event Description

Blood products initiated during first unit of packed rbc blood noted dripping from buddy lite warmer device.Upon opening the warmer to inspect the cartridge, blood sprayed on wall and ceiling of aircraft.Cartridge was noted to have a pin hole in the membrane.No prior damage of the cartridge noted prior to use.Tubing changed out without add'l issues.

• Brand Name: BUDDY LITE FLUID WARMER
• Type of Device: BUDDY LITE
• Manufacturer (Section D): BELMONT INSTRUMENTS; billerica ME 01821
• MDR Report Key: 4953258
• MDR Text Key: 6633525
• Report Number: MW5044920
• Device Sequence Number: 1
• Product Code: BSB
• 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: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 905-00017
• Device Lot Number: 2014-1101
• Other Device ID Number: 905-00010P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 100