MAUDE Adverse Event Report: BELMONT INSTRUMENT LLC THE BELMONT RAPID INFUSER; THERMAL INFUSION FLUID WARMER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Shock (2072); No Known Impact Or Consequence To Patient (2692)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

The unit has not been returned for investigation and we are therefore unable to determine the root cause of the hypotensive event at this time.Several attempts have been made to contact the customer; however, as of the date of this report, no additional information has been provided.Therefore, belmont requested an independent medical doctor review of the initial report from the user facility.The medical review does not concur with the customer's conclusion based on the facts provided.Without additional information, it is difficult to determine what occurred in this incident.It was reported that the patient recovered and was discharged.Should additional information become available, a supplemental report will be submitted accordingly.

Event Description

The report from the user facility stated: "a (b)(6) female patient was undergoing an extensive spinal surgery.Approximately 2 1/2 hours after a blood transfusion, the patient became profoundly hypotensive (40/20).The patient responded to resuscitation but then became hypotensive again.The spinal surgery was aborted.An echocardiogram demonstrated profound vasodilation consistent with anaphylactic transfusion reaction.This is the fourth occurrence of this at this facility.All four cases involved the belmont fluid management system.Anecdotally, this reaction does not appear to occur with regular tubing.The patient was diagnosed with distributive shock.It could not be determined if the distributive shock was neurogenic (due to the spinal surgery) versus anaphylactic.The other two causes (septic and adrenal crisis) of distributive shock were ruled out.The patient recovered and was discharged.".

• Brand Name: THE BELMONT RAPID INFUSER
• Type of Device: THERMAL INFUSION FLUID WARMER
• Manufacturer (Section D): BELMONT INSTRUMENT LLC; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT INSTRUMENT LLC; 780 boston road; billerica MA 01821
• Manufacturer Contact: sabrina belladue ; 780 boston road; billerica, MA 01821 ; 9783307637
• MDR Report Key: 7828343
• MDR Text Key: 119043819
• Report Number: 1219702-2018-00026
• Device Sequence Number: 1
• Product Code: LGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Life Threatening