BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE

    MDR report key: 6835608 · Received August 31, 2017

    Report

    Report Number
    2016493-2017-00556
    Event Type
    Injury
    Date Received
    August 31, 2017
    Date of Event
    August 17, 2017
    Report Date
    August 17, 2017
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT: PRI TUBING, 60ML MONOJECT SYRINGE, THERAPY DATE: (B)(6) 2017. THE CUSTOMER¿S REPORT THAT THE PCA STOPPED FUNCTIONING DURING PATIENT USE WAS CONFIRMED. REVIEW OF THE PCU EVENT LOG SHOWS THAT THE PCA MODULE WAS PROGRAMMED TO INFUSE HYDROMORPHONE 10MG IN 50ML AT 12:41 AM ON (B)(6) 2017. BECAUSE THE SAME PATIENT WAS SELECTED, THIS KEPT THE PREVIOUS HYDROMORPHONE PARAMETERS OF 0.3MG FOR THE PCA DOSE, 20 MINUTES FOR THE LOCKOUT INTERVAL AND 0.3MG/1HR FOR THE MAX LIMIT. A PCA REQUEST WAS MADE AND DELIVERED 0.3MG AT 12:43 AM. AT 1:13 AM, ANOTHER PCA REQUEST WAS MADE; HOWEVER, IT WAS NOT DELIVERED BECAUSE THIS REQUEST PUT THE MAX LIMIT OVER THE THRESHOLD OF 0.3MG/1HR SINCE IT HAD JUST DELIVERED 0.3MG. IT WAS ALSO REPORTED THAT THE ALARM DID NOT STOP, HOWEVER THE LOG SHOWS THAT THE USER PRESSED RESTART SEVERAL TIMES AND THE TAMPER SWITCH AND CHANNEL SELECT BUT DID NOT SILENCE THE MAX LIMIT ALARM UNTIL AFTER 30 SECONDS. THE USER TRIED TO RESTART THE INFUSION AGAIN BUT THE DEVICE WAS STILL IN A MAX LIMIT STATE. THE DEVICE ALARMED FOR DOOR OPEN AND CHECK SYRINGE AND THE USER EVENTUALLY CHANNELED OFF THE DEVICE AND POWERED OFF THE SYSTEM. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE WAS USER PROGRAMMING. NO DEVICES RECEIVED, LOG REVIEW ONLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PCA WAS PROGRAMMED TO INFUSE 0.3MG HYDROMORPHONE EVERY 20 MINUTES IF NEEDED WITH A MAXIMUM HOUR DOSE OF 0.3 MG. THE PCA WOULD NOT DELIVER THE DOSE WHEN REQUESTED AND WHEN THE PATIENT REACHED THE MAXIMUM DOSE THE PCA WOULD NOT STOP ALARMING. THERE WAS NO REPORT OF PATIENT HARM HOWEVER THE PATIENT DID NOT RECEIVE ADEQUATE PAIN RELIEF. THE PATIENT'S PAIN MEDICATION WAS CHANGED TO PRN IVP DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614972 ALARIS PCA MODULE PUMP, INFUSION FRN CAREFUSION 8120

    Patients

    Seq Age Sex Outcome Treatment
    1 Other