FDA Adverse Event Malfunction Summary report: N

MRIDIUM MRI INFUSION SET

MDR report key: 3062564 · Received March 26, 2013

Report

Report Number
3062564
Event Type
Malfunction
Date Received
March 26, 2013
Date of Event
March 13, 2013
Report Date
March 26, 2013
Manufacturer
IRADIMED CORPORATION
Product Code
FRN
Product Problem
Yes
Report Source
User Facility report
Reporter Location
TX, US

Narratives

Description of Event or Problem · 1

ANESTHESIOLOGIST SET MRI PUMP TO ADMINISTER PROPOFOL DURING THE MRI. DOCTOR SET UP THE TUBING, PRIMED THE TUBING, AND SET UP THE RATE AND DOSE TO BE GIVEN. MRI SCAN BEGAN. APPROXIMATELY FIFTEEN (15) MINUTES LATER, DOCTOR NOTED THAT THE OXYGEN SATS WERE DECREASING, AND HE PLACED A NASAL TRUMPET TO ASSIST WITH OPENING THE AIRWAY. AFTER PLACING THE NASAL TRUMPET, DOCTOR NOTED THAT THE 1ST 50 ML BOTTLE OF PROPOFOL WAS EMPTY. FOUR (4) MINUTES LATER, DOCTOR THEN HUNG THE 2ND 50 ML BOTTLE OF PROPOFOL AFTER CONFIRMING THE RATE OF INFUSION AND THE VOLUME INFUSED ON THE MRI INFUSION PUMP THE PROPOFOL WAS RUNNING ON. MRI SCAN RESTARTED AT THAT TIME. TEN (10) MINUTES LATER, DOCTOR NOTED THAT THE SATS CONTINUED TO BE LOW AND STOPPED MRI SCAN; AT THAT TIME DOCTOR NOTICED THAT THE SECOND 50 ML BOTTLE OF PROPOFOL WAS EMPTY EVEN THOUGH THE MONITOR STATED IT HAD DELIVERED APPROXIMATELY 8-9 ML. DOCTOR SHUT OFF THE PROPOFOL AND DISCONNECTED IT FROM THE PATIENT AND HOOKED THE LACTATED RINGERS BACK UP AND STARTED INFUSION. DOCTOR STARTED BAG MASK VENTILATION ON PATIENT TO HELP ASSIST WITH RESPIRATIONS. PATIENT STABILIZED AND MRI COMPLETED. NO ADVERSE PATIENT OUTCOME.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MRI TO BE COMPLETED UNDER PROPOFOL SEDATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.DEVICE #2IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
124339 MRIDIUM MRI INFUSION SET PUMP, INFUSION SET FRN IRADIMED CORPORATION * *
124340 MRIDIUM MRI INFUSION PUMP PUMP, INFUSION FRN IRADIMED CORPORATION 3860 PLUS *

Patients

Seq Age Sex Outcome Treatment
1 28 MO YES, THERE WAS IV TUBING AND AN INFUSION PUMP IN| USE.