FDA Adverse Event Malfunction Summary report: N

RAPID INFUSER RI-2, 120V, 750 ML/MIN

MDR report key: 19509204 · Received June 11, 2024

Report

Report Number
19509204
Event Type
Malfunction
Date Received
June 11, 2024
Date of Event
January 14, 2024
Report Date
February 15, 2024
Manufacturer
BELMONT INSTRUMENT LLC
Product Code
LGZ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AZ
Reporter Occupation
RISK MANAGER
Health Professional
N

Narratives

Description of Event or Problem · 0

PATIENT CAME IN TO EMERGENCY DEPARTMENT (ED) WITH MULTIPLE GUNSHOT WOUNDS TO TORSO. MASSIVE TRANSFUSION PROTOCOL WAS STARTED USING BELMONT RAPID INFUSER. PATIENT TAKEN TO OPERATING ROOM FOR EXPLORATORY LAPAROSCOPY. DURING THE 4TH ROUND OF MEDIA TRANSFER PROTOCOL (MTP) ADMINISTRATION, THE PRIMARY OR BELMONT UNEXPECTEDLY SHUT DOWN WITHOUT WARNING. A MEMBER OF THE OR TEAM RAN TO RETRIEVE THE BELMONT FROM THE CARDIOVASCULAR OPERATING ROOM (CVOR). ONCE THE CVOR BELMONT ARRIVED, IT WAS SET UP, BUT THEN THEY REALIZED IT WAS ALSO MALFUNCTIONING ¿ IT WAS UNABLE TO HEAT THE BLOOD, AND IT RESTRICTED THE ADMINISTRATION SPEED TO 50CC/HOUR. THE PATIENT WAS EXPERIENCING SUBSTANTIAL BLOOD LOSS AND OCCASIONAL HEMODYNAMIC INSTABILITY, SO THEY THEN CONTACTED THE ED TO HAVE THEM BRING A BELMONT FROM THE ED UP TO THE OR FOR THEM TO USE. THE BELMONT THEY GOT FROM THE ED DID NOT MALFUNCTION, AND ALLOWED THE TEAM TO GIVE TWO MORE ROUNDS OF MTP. THE PATIENT HAS RECOVERED, ALTHOUGH HE HAS ENDED UP WITH A COLOSTOMY. THE FIRST BELMONT MACHINE, THAT SHUT DOWN UNEXPECTEDLY, WAS PURCHASED BY OUR HOSPITAL OVER A YEAR AGO AND PUT INTO USE IN THE HOSPITAL IN [DATE REDACTED]. IT HAD PREVENTATIVE MAINTENANCE DONE IN [DATE REDACTED]. THE SECOND MACHINE, THE ONE THAT WOULDN'T HEAT THE BLOOD PROPERLY, WAS PURCHASED NEW IN [DATE REDACTED]. BOTH MACHINES HAVE BEEN SENT BACK TO THE MANUFACTURER BECAUSE THEY ARE STILL UNDER WARRANTY. WE HAVE NOT HEARD BACK FROM THE MANUFACTURER YET.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
813871 RAPID INFUSER RI-2, 120V, 750 ML/MIN WARMER, THERMAL, INFUSION FLUID LGZ BELMONT INSTRUMENT LLC 903-00039

Patients

Seq Age Sex Outcome Treatment
1 30 YR Male