BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS® PCA MODULE

    MDR report key: 7834627 · Received August 30, 2018

    Report

    Report Number
    2016493-2018-00655
    Event Type
    Injury
    Date Received
    August 30, 2018
    Date of Event
    July 30, 2018
    Report Date
    August 3, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED. BECAUSE NO DEVICE OR DEVICE LOGS WERE RETURNED OR EXPECTED TO BE RETURNED, NO FAILURE INVESTIGATION COULD BE PERFORMED. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING INFUSIONS ON THE SYRINGE AND PCA MODULES, WHEN THE LINE IS CLAMPED FOR A SIGNIFICANT PERIOD OF TIME, THE PUMP DOES NOT ALERT THE NURSE, THEREFORE, THE PATIENT DOES NOT RECEIVE MEDICATION DURING THAT TIME PERIOD. IN ONE INSTANCE, MORPHINE WAS PROGRAMMED TO INFUSE AT 1ML/HR WITH BOLUSES OF 0.5ML EVERY 15 MINUTES AND WAS ADMINISTERED DURING THE DATE RANGE OF (B)(6) 2018. AT 2000 ON (B)(6) 2018, IT APPEARED THAT THE PATIENT DID NOT RECEIVE THE MEDICATION. THE NON-BD SYRINGE WAS NOTED TO BE FULL, CRACKED AND LEAKING WITH THE LINE INADVERTENTLY LEFT CLAMPED SINCE THE INFUSION WAS STARTED AT 0202. THE DEVICE DID NOT ALARM FOR OCCLUSION AND THE PRESSURE SETTING WAS LIKELY SET TO HIGH AND LOCKED. THE PATIENT WAS ALSO RECEIVING SCHEDULED IBUPROFEN. THE PAIN SCALE DURING THAT TIME WAS "SLEEPING TO10". THE PCA CONTINUOUS INFUSION WAS SET TO 0ML/HR ON (B)(6) 2018 (WITH JUST BOLUS AVAILABLE) AND WAS TRANSITIONED TO INTERMITTENT MORPHINE DOSING ON (B)(6) 2018. NO PRODUCT WAS SEQUESTERED FOR INVESTIGATION. THE CUSTOMER REPORTED SIMILAR EVENTS OCCURRED IN NICU, PICU AND ON THE MEDICAL SURGICAL UNIT, BUT NO ADDITIONAL INFORMATION ABOUT PATIENTS, MEDICATIONS, OR EVENTS WERE PROVIDED FOR THOSE INSTANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674883 ALARIS® PCA MODULE PUMP, INFUSION FRN CAREFUSION 8120

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other