BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM MRI INFUSION PUMP

    MDR report key: 1012743 · Received March 12, 2008

    Report

    Report Number
    3005053560-2008-00001
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 8, 2008
    Report Date
    March 8, 2008
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT FROM THE HEALTH CARE PROFESSIONAL INDICATED THAT THE DEVICE (INFUSION PUMP AND BATTERY PACK) WAS EVALUATED BY THE HOSP STAFF. FOLLOWING THE EVENT, A REP FROM IRADIMED CORP VISITED THE FACILITY TO EXAMINE THE EQUIPMENT. THIS EQUIPMENT WAS EVALUATED ON-SITE AND RETURNED TO IRADIMED CORP FOR FURTHER ANALYSIS. INFO WAS OBTAINED FROM CUSTOMER INTERVIEWS, PHOTOGRAPHS, AND AN INSPECTION OF THE DAMAGED EQUIPMENT. THE BIOMEDICAL ENGINEER MGR AND HIS STAFF, AND THE MRI CLINICAL SVS MGR, AND HER STAFF, AND THE MAINTENANCE WORKERS WERE INTERVIEWED REGARDING THE OPERATION AND USE OF THE DEVICE. INFO GATHERED DURING THIS PERIOD IS BEING USED TO RECONSTRUCT THE EVENT TO ESTABLISH THE POSSIBLE CAUSE(S) OF THE EVENT. RESULTS: A 3855 REMOTE CONTROL UNIT AND 1133 BATTERY PACK WERE MATED TOGETHER FOR CHARGING IN THE CONTROL ROOM. BOTH THESE PRODS ARE COMPONENTS OF THE MRIDIUM 3850 INFUSION PUMP SYS. THE MIRIDIUM 3850 PUMP WAS INSIDE THE MRI MAGNET ROOM AT THE TIME AND WAS NOT IN USE AT THE TIME OF THE EVENT. AN ULTRASOUND TECH WENT TO AN ADJOINING AREA WITH THE MRI, AND DISCOVERED SMOKE COMING FROM THE 3855 AND 1133 ASSEMBLIES. THE SMOKE RESULTED FROM THE INTERNAL FAILURE OF A BATTERY CELL INSIDE THE 1133 BATTERY PACK. WHEN THE FAILURE OCCURRED, THE TECHNICIAN RAISED A CODE RED ALARM, AND 2 MAINTENANCE WORKERS CAME TO THE CONTROL ROOM AND EXTINGUISHED THE SMOLDERING 3855 REMOTE DISPLAY UNIT AND 1133 BATTERY PACK WITH A FIRE EXTINGUISHER, AND AFTER THE SMOLDERING WAS STOPPED, THEY PLACED THE UNIT INTO A BUCKET WITH WATER TO ENSURE THE SMOLDERING HAD ENDED. THIS ALL OCCURRED WITHIN THE FIRST 2 MINS OF THE EVENT. THERE WAS SMOKE PRESENT IN THE CONTROL ROOM, BUT THE EXTENT OF THIS DAMAGE WAS MINIMAL (SMOKE RESIDUE ON THE COUNTER AND BACK WALL WHERE THE REMOTE UNIT WAS POSITIONED). NO ONE WAS HURT AS A RESULT OF THE EVENT, NOR WAS THERE ANY PROPERTY DAMAGE, OTHER THAN THE DAMAGE TO THE 3855 REMOTED DISPLAY UNIT AND 1133 BATTERY PACK. THE DAMAGED UNIT WAS MOVED TO THE BMET SHOP, AND WAS MADE AVAILABLE FOR IRADIMED CORP INSPECTION. THE HOSP CONTACTED IRADIMED CORP BY PHONE ON FEBRUARY 8, 2008, AND PRELIMINARY INFO WAS OBTAINED. PHOTOS OF THE DAMAGED EQUIPMENT WERE REC'D FROM THE HOSP AT THIS TIME. AFTER THE INITIAL REVIEW OF THE FACTS, IT WAS DETERMINED TO SEND AN IRADIMED CORP REP TO THE FACILITY TO GATHER ADD'L INFO. ON FEBRUARY 14, THE REP VISITED THE HOSP AND EXAMINED THE 3855 REMOTED DISPLAY UNIT AND 1133 BATTERY PACK IN QUESTION. EXAMINATION OF THE 3855 REMOTED DISPLAY UNIT AND 1133 BATTERY PACK INDICATED THAT BOTH THE 3855 AND 1133 HAD BEEN DAMAGED BY THE HEAT PRODUCED DURING THE 1133 BATTERY PACK FAILURE. THE CASING OF THE BATTERY PACK HAD BEEN MELTED, AND THE INTERNAL ASSEMBLIES OF THE BATTERY CELLS AND CIRCUIT BOARD WERE DAMAGED. THE 1133 BATTERY PACK ASSEMBLY HAD MELTED THROUGH THE BATTERY CHARGING "BAY" ON THE 3855 REMOTED DISPLAY UNIT. ONE OF THE MAINTENANCE WORKERS HAD MOVED THE 1133 BATTERY PACK WITH THE NOZZLE OF THE FIRE EXTINGUISHER, AND THE BATTERY PACK FELL BACKWARD AWAY FROM THE 3855 UNIT. THE 3855 AND 1133 BATTERY PACK WERE STORED IN THE BIOMEDICAL ENGINEERING DEPT AND MATCHED THE PHOTOGRAPHS DESCRIBING THE EVENT. BOTH UNITS WERE BAGGED AND BOXED, AND SHIPPED TO IRADIMED CORP FOR FURTHER EXAMINATION.

    Description of Event or Problem · 1

    DURING BATTERY CHARGING IN THE MRI CONTROL ROOM, THE MODEL 1133 BATTERY PACK FAILED, AND MELTED THE BATTERY PACK CASE AND DAMAGED THE MODEL 3855 REMOTE DISPLAY UNIT. NO INJURY RESULTED FROM THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MRIDIUM MRI INFUSION PUMP INFUSION PUMP FRN IRADIMED CORPORATION 1133

    Patients

    Seq Age Sex Outcome Treatment
    1
    2
    3