BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA PUMP TUBING

    MDR report key: 8895352 · Received August 14, 2019

    Report

    Report Number
    9616066-2019-02325
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 2, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ONLY REQUESTED A LOG REVIEW FOR A SPECIFIC INQUIRY. REVIEW OF THE EVENT LOG SHOWS THE PCU WAS POWERED ON. PCA WAS SEEN AS ATTACHED (LABELED AS B); PRIMARY VOLUME INFUSED OF 0ML; SECONDARY VOLUME INFUSED OF 0ML. PCA WAS PROGRAMMED TO INFUSE DRUG ID 548 (ACTUAL DRUG UNKNOWN DUE TO DATASET NOT RECEIVED); INFUSION MODE PCA ONLY; LOCKOUT INTERVAL 10 MINUTES; SYRINGE TYPE IMS_30; VOLUME 28.1679ML; RATE 150ML/H; VTBI 5ML. AT 9:24AM-9:27AM - PCA DOSE WAS REQUESTED; 5ML WAS INFUSED. AT 10:36AM - PCA WAS PROGRAMMED FOR VOLUME TO BE INFUSED OF 1ML FOR EACH DOSE REQUEST. [TOTAL OF 23 PCA DOSE REQUESTS OF 1ML EACH WERE INFUSED DURING THIS PERIOD]. AT 5:59PM - PCA SYRINGE SHOWS AS EMPTY. PRIMARY VOLUME INFUSED SHOWS AS 28ML. AT 6:13PM - PCA SYRINGE WAS REPLACED HAVING VOLUME OF 32.4585ML. PCA WAS PROGRAMMED TO CONTINUE TO INFUSE SAME DRUG ID. [TOTAL OF 28 PCA DOSE REQUESTS OF 1ML EACH WERE INFUSED DURING THIS PERIOD]. ON (B)(6) 2019 AT 9:19AM THE PCU WAS POWERED OFF. PCA SHOWED TOTAL VOLUME INFUSED OF 56ML. THE ROOT CAUSE WAS NOT IDENTIFIED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED AN UNKNOWN PERSON CUT THE IV LINE IN AN ATTEMPT TO COLLECT REMAINING MORPHINE MEDICATION. THERE WAS NO PATIENT HARM. THE PATIENT HAD A TOTAL OF TWO 30ML SYRINGES (60 ML TOTAL) HUNG BETWEEN (B)(6) 2019 AT 0600 AND (B)(6) 2019 AT 1424 DURING THEIR HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689388 ALARIS PCA PUMP TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION PCA TUBE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR