FDA Adverse Event Malfunction Summary report: N

RAPID INFUSER, FMS2000

MDR report key: 7032517 · Received November 15, 2017

Report

Report Number
7032517
Event Type
Malfunction
Date Received
November 15, 2017
Date of Event
November 1, 2017
Report Date
November 10, 2017
Manufacturer
BELMONT INSTRUMENT CORPORATION
Product Code
FRN
Product Problem
Yes
Report Source
User Facility report
Reporter Location
IA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

PATIENT ARRIVED AT EMERGENCY DEPARTMENT (ED) VIA LIFE FLIGHT FROM SCENE OF A MOTOR VEHICLE ACCIDENT WHERE THE PATIENT WAS DRIVER AND WAS THROWN FROM VEHICLE. EMS ARRIVED ON SCENE & NOTED PATIENT HAD NO PULSE; CPR STARTED & PULSE RETURNED BY ARRIVAL IN ED. PATIENT WAS UNCONSCIOUS ON ARRIVAL IN ED WITH GLASGOW SCORE 3, PUPILS FIXED & DILATED. BLOOD PRODUCTS WERE ORDERED TO BE GIVEN BY BELMONT RAPID INFUSER DURING A TRAUMA ALERT. TUBING WAS PRIMED AND PASSED ALL CHECKS PRIOR TO THE BLOOD PRODUCTS BEING HUNG. NURSE BEGAN TO INFUSE THE FIRST UNIT OF PACKED RED BLOOD CELLS AND WITHIN 1 MINUTE INTO THE INFUSION ANOTHER STAFF MEMBER ACROSS THE ROOM NOTED THAT BLOOD WAS COMING FROM THE BOTTOM OF THE INFUSER. BELMONT WAS STOPPED AND UNHOOKED FROM THE PATIENT. THIS CAUSED DELAY IN PROVIDING BLOOD PRODUCTS TO THE PATIENT AND WASTAGE OF 1 UNIT OF BLOOD. ADDITIONAL UNITS OF BLOOD WERE ADMINISTERED AFTER THIS OCCURRENCE. PATIENT EXPIRED IN ED FROM EXTENSIVE INJURIES RELATED TO THE MOTOR VEHICLE CRASH. AFTER FULL MEDICAL EVALUATION, IT WAS DETERMINED HIS INJURIES WERE NOT SURVIVABLE. THE BELMONT PUMP FAILURE DID NOT HAVE A ROLE IN THE PATIENT'S DEATH. PUMP AND TUBING WERE SAVED. IN-HOUSE CLINICAL ENGINEERING EVALUATED THE BELMONT PUMP FOR ANY MECHANICAL ISSUES AND WILL CONTACT THE MANUFACTURER. ====================== MANUFACTURER RESPONSE FOR RAPID INFUSER PUMP, BELMONT RAPID INFUSER PUMP (PER SITE REPORTER) ====================== CLINICAL ENGINEERING IS NOTIFYING THE MANUFACTURER (BELMONT) TO SHARE RESULTS OF IN-HOUSE NON-DESTRUCTIVE TESTING; THERE IS NO EVIDENT INDICATOR ON THE DEVICE OR TUBING FOR THE CAUSE OF THE LEAK. CLINICAL ENGINEERING ATTEMPTED TO INSET A NEW LINE SET AND TEST THE DEVICE USING WATER. UPON POWERING IT ON, THE DEVICE INDICATED THAT IT HAS LOST ITS CALIBRATION, SO FURTHER TESTING IN-HOUSE WAS STOPPED. MANUFACTURER WILL REQUEST RETURN OF THE BELMONT PUMP & TUBING FOR FURTHER TESTING; REQUEST THAT MANUFACTURER SHARE THEIR FINDINGS WITH HOSPITAL.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
813655 RAPID INFUSER, FMS2000 PUMP, INFUSION FRN BELMONT INSTRUMENT CORPORATION 903-00023

Patients

Seq Age Sex Outcome Treatment
1 28 YR BELMONT TUBING CONNECTED TO THE BELMONT RAPID INFU