MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT HYPERTHERMIA PUMP; THERMAL INFUSION FLUID WARMER

Model Number	INFLOW/OUTFLOW BIFURCATED OUTFLOW KIT
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The implicated disposable set was not available for investigation.Upon reviewing photos provided by the distributor, it appears that there was a flash partially blocking inside the tip of the tubing.The retain sample for the associated lot was inspected and no evidence of any blockages were found.The manufacturing records for this lot were also reviewed and no anomalies were identified.A review of complaints for the past year indicated that here have been no additional reports of this nature; it appears that this was an isolated incident.It was reported that the procedure was completed without any further issues; no patient injury was reported.All associated personnel have been made aware of this incident.We will continue to monitor and trend similar reports of this nature going forward.Should additional information become available, a supplemental report will be provided.
Event or Problem Description
Our distributor received a complaint from a user facility and relayed the following report: it was reported by the customer that they had a faulty/defective bifurcated patient line disposable during a case on 07oct2019 in thailand.One of the four bifurcated tubes (outflow) looked abnormal right after opening the set, but they proceeded with the case using the implicated set.A short time into the procedure the tube became completely blocked; the doctor paused the treatment and opened the tube using a needle.(their comment is that it looks like a hard glue blocking the tube).They reconnected everything and the procedure was completed without issue.

• Brand Name: THE BELMONT HYPERTHERMIA PUMP
• Common Device Name: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 9293991
• Report Number: 1219702-2019-00081
• Device Sequence Number: 2310427
• Product Code: LGZ
• UDI-Device Identifier: 00896128002220
• UDI-Public: 00896128002220
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K152208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/07/2019

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 Expiration Date: 03/31/2022
• Device Model Number: INFLOW/OUTFLOW BIFURCATED OUTFLOW KIT
• Device Catalogue Number: 902-00038
• Device Lot Number: 2019-03 12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 11/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1