MAUDE Adverse Event Report: BELMONT INDUSTRIES BUDDY LITE DISPOSABLE SETS; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION

Model Number	905-00010P
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Critical patient being airlifted to healthcare facility.During transport, when the nurse was hanging the first unit of blood, the buddy lite tubing cracked after blood was primed through the buddy lite unit.Because the leaking blood was highly visible, there was minimal blood lost from the unit.New buddy lite tubing was placed and the transfusion continued without further delay/issues.This is the eighth reported event involving cracked buddy lite tubing that has occurred in 2017.The first four events were reported via voluntary reports.Event #5: during air transport, a buddy lite cassette leaked blood during blood transfusion.There was no harm to patient because of active recovery by staff.Event #6: during air transport, a unit of packed red blood cells were being administered with the buddy lite blood warmer.After 10 to 15 minutes of infusing, there was blood draining out of the heating element.It appeared that the insert that goes inside the warmer melted/ruptured.The infusion was discontinued due to membrane rupture.No harm to patient.Event #7: during air transport, one unit of packed red blood cells was being administered using the inline blood warmer.The fluid warmer tubing cracked at the circular disc part of the tubing.The blood was at the end of transfusing resulting in minimal blood leakage.No harm to patient.Action plan: trailing a new replacement product.Manufacturer response for warmer, blood, non-electromagnetic radiation, buddy lite disposable sets (per site reporter).Earlier in year, we met with the company representative to make certain that we are using the product correctly.

• Brand Name: BUDDY LITE DISPOSABLE SETS
• Common Device Name: WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
• Manufacturer (Section D): BELMONT INDUSTRIES
• MDR Report Key: 8435882
• Report Number: 8435882
• Device Sequence Number: 14015599
• Product Code: BSB
• UDI-Device Identifier: 00896128002091
• UDI-Public: 00896128002091
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/17/2017
• Report Date (Section F): 10/17/2017

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: No Information
• Device Model Number: 905-00010P
• Device Lot Number: 2016-05 04
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Date Report to Manufacturer: 10/20/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/17/2017