MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT BUDDY LITE BLOOD/FLUID WARMER; THERMAL INFUSION FLUID WARMER

Model Number BUDDY LITE

Device Problems Material Rupture (1546); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Neither the buddy lite nor the associated disposable set have been returned to belmont for investigation.Follow up with the user facility revealed that the reported issue with the disposable set was a leakage of the microporous membrane, rather than a burst.This can occur if fluid is introduced prior to installing the disposable set into the heater unit, which is not in accordance with the instructions for use; however without investigating the device, a root cause of the reported leak or dislodged heater plate cannot be established.The following warning statements are provided in the operator's manual: "do not open the heater unit during or after priming" and "do not attempt to prime unit or subject the disposable to flow outside of the heater unit, as the disposable set will be damaged." the manufacturing records of the buddy lite were reviewed and no anomalies were identified.The batch records for the associated disposable set could not be reviewed, as no lot number was provided.All buddy disposable sets are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.It was reported that there was no patient injury or delay in care as a result of the incident.Belmont has requested that the buddy lite be returned for further investigation.Should additional information become available, a supplemental report will be provided.

Event Description

Belmont's sales representative received a report from the user facility that the disposable set burst inside the buddy lite and dislodged the heating plate.

• Brand Name: THE BELMONT BUDDY LITE BLOOD/FLUID WARMER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 11181317
• MDR Text Key: 233036699
• Report Number: 1219702-2021-00013
• Device Sequence Number: 1
• Product Code: BSB
• UDI-Device Identifier: 20896128002491
• UDI-Public: (01)20896128002491
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090508
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 01/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BUDDY LITE
• Device Catalogue Number: 905-00017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1