MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER

Model Number 3-SPIKE DISPOSABLE SET

Device Problem Material Separation (1562)

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

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

The 3-spike disposable set involved in the incident was not available for investigation.The library/retain sample for this lot number was reviewed, and no defects were noted.The manufacturing batch records for this lot were also reviewed, and no anomalies were identified.Without evaluating the set, the root cause cannot be determined.No patient injury was reported.All 3-spike disposable sets are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.A review of past complaints indicates that there has only been one other report associated with this lot number.Following receipt of the complaint, belmont contacted the distributor to obtain further information about the case and to discuss proper spiking techniques.Additional testing has been performed to ensure that the leak test challenges the bond of the tubing to the spike.Belmont will continue to monitor and trend similar reports of this nature and take further action if required.Should additional information become available, a supplemental report will be provided.

Event Description

Belmont's distributor received a report from the user facility that two spikes disconnected from the tubing of a 3-spike disposable set during a massive transfusion.

Manufacturer Narrative

The 3-spike disposable set involved in the incident was not available for investigation.The library/retain sample for this lot number was reviewed and no defects were noted.The manufacturing batch records for this lot were also reviewed and no anomalies were identified.Without evaluating the set, the root cause cannot be determined.No patient injury was reported.All 3-spike disposable sets are 100% leak tested and 100% visually inspected prior to release from belmont medical technologies.A review of past complaints indicates that there has only been one other report associated with this lot number, which upon follow-up with the user facility was reported to be the result of user error and not the result of any potential malfunction (please refer to mfr report #1219702-2020-00083 in response to uf report #(b)(4)).Following receipt of the complaint, belmont contacted the distributor to obtain further information about the case and to discuss proper spiking techniques.Additional testing has been performed to ensure that the leak test challenges the bond of the tubing to the spike.Belmont will continue to monitor and trend similar reports of this nature and take further action if required.Should additional information become available, a supplemental report will be provided.

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• MDR Report Key: 10872083
• MDR Text Key: 217712403
• Report Number: 1219702-2020-00104
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 00896128002022
• UDI-Public: (01)00896128002022(17)230531(10)20200503
• Combination Product (y/n): N
• PMA/PMN Number: K141654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/20/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 3-SPIKE DISPOSABLE SET
• Device Catalogue Number: 903-00006P
• Device Lot Number: 2020-05 03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1