MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT BUDDY LITE BLOOD/FLUID WARMER; BLOOD AND PLASMA WARMING DEVICE

Catalog Number	905-00017
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The buddy lite has not been returned for investigation, nor has the serial number or lot number of the disposable set been provided.It was reported that the user was delivering blood through the buddy lite, utilizing a baxter sigma iv pump; however, the buddy lite is designed for gravity flow only.The operator's manual cautions the user: "the system should not be used with pressure infusers.Blood and fluid bags contain air.The set can vent large amounts of air from crystalloid, but with blood only small amounts of air can be vented." the manual also provides the following warning statement: "do not attempt to prime unit or subject the disposable to flow outside of the heater unit, as the disposable will be damaged." belmont's clinical specialist has visited the user facility to provide additional training to the staff.Should additional information become available, a supplemental report will be submitted accordingly.
Event or Problem Description
Belmont's clinical specialist received a complaint from the user facility and relayed the following report: "user was delivering rbc at 60ml/hour through the buddy lite utilizing the baxter sigma iv pump on a broviac cathether.During the infusion, it was recognized that the pressure relief valve on the buddy lite disposable was leaking.The tubing was replaced, the infusion was continued, the flow rate was set at 50ml/hour and then was raised up to 60ml/hour again and the remainder of the 150ml of blood was delivered to the patient.At the very end of the delivery, the pressure relief valve leaked again.Charlene will visit the facility today to see how the buddy lite was/is utilized.The facility was looking to see if there is a way that the buddy lite can be utilized with an iv pump for blood delivery.".

• Brand Name: THE BELMONT BUDDY LITE BLOOD/FLUID WARMER
• Common Device Name: BLOOD AND PLASMA WARMING DEVICE
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 8810152
• Report Number: 1219702-2019-00048
• Device Sequence Number: 19634757
• Product Code: BSB
• UDI-Device Identifier: 20896128002491
• UDI-Public: 20896128002491
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K090508
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 905-00017
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 07/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1