BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE

    MDR report key: 5915745 · Received August 30, 2016

    Report

    Report Number
    2016493-2016-00633
    Event Type
    Malfunction
    Date Received
    August 30, 2016
    Date of Event
    April 18, 2016
    Report Date
    July 7, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): A 100ML VIAL FRESENIUS KABI NDC 63323-269-67, LOT 16II2159, EXP 08/2017, DIPRIVAN; NON-CFN SECONDARY SET; A 100ML BAXTER BAG NDC 0338-0017-48, LOT P337279, EXP JAN 2017, 5% DEXTROSE. A 1000ML BAXTER BAG NDC 0338-0049-04, LOT Y008805, EXP JUL 2017, 0.9% SODIUM CHLORIDE; (2) NON-CFN EXTENSION SETS; 250ML BAXTER NDC 0338-0017-02, LOT Y007383, EXP JUN 2017, 5% DEXTROSE, 200ML BAXTER NDC 43066-360, NEXTERONE. A 1000ML BAXTER NDC 0338-0049-04, LOT Y008805, EXP JUL 2017, 0.9% SODIUM CHLORIDE; THERAPY DATE (B)(6) 2016. CONCLUSION CODE: NO AVAILABLE CODE FOR UNDETERMINED OR UNKNOWN CAUSE. THE CUSTOMER¿S REPORT OF A CHANNEL ERROR 240.4150 HAVING OCCURRED DURING AN INFUSION WAS CONFIRMED. THE PCU EVENT LOG SHOWED THAT ON (B)(6) 2016 AT 4:22PM THE SOURCE PUMP MODULE EXPERIENCED A CHANNEL ERROR MALFUNCTION WITH THE UPPER PRESSURE SENSOR THAT RESULTED IN ERROR CODE 240.4150.0; AN UPPER PRESSURE SENSOR READING HIGH FAILURE. IT WAS NOTED DURING THE INVESTIGATION THAT THIS PUMP MODULE HAD EXPERIENCED THE SAME CHANNEL ERROR MALFUNCTION A DAY PRIOR ON 17APR2016 AT 12:41PM THAT WAS NOT REPORTED BY THE CUSTOMER. FUNCTIONAL TESTING FOUND THE UPPER PRESSURE SENSOR OUTPUT WAS INTERMITTENTLY PRODUCING ITS ¿RAIL¿ VOLTAGE WHICH IS AN OUTPUT CONSIDERED TOO HIGH FOR THE UPPER PRESSURE SENSOR UNDER NORMAL OPERATING CONDITIONS. THE PROXIMATE CAUSE FOR THE CUSTOMER¿S REPORTED EXPERIENCE IS BEING ATTRIBUTED TO AN INTERMITTENTLY MALFUNCTIONING UPPER PRESSURE SENSOR FAILURE. THE ROOT CAUSE FOR THE INTERMITTENT MALFUNCTIONING PRESSURE SENSOR WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AN UNSPECIFIED 'PRESSOR' INFUSION DISPLAYED A 'FATAL COMMUNICATION ERROR' (ERROR CODE 240.4150) AND SHUT OFF WHILE ON A PATIENT. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564828 ALARIS® PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1