BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS® PUMP MODULE ADMINISTRATION SET

    MDR report key: 8060433 · Received November 12, 2018

    Report

    Report Number
    9616066-2018-02170
    Event Type
    Malfunction
    Date Received
    November 12, 2018
    Report Date
    October 17, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO INITIAL REPORT DATE OF REPORT.

    Additional Manufacturer Narrative · 0

    DUE TO THE POTENTIAL FOR HIV EXPOSURE DURING RECEIVING AND INVESTIGATION, IT WAS DECIDED THAT THESE SETS WOULD NOT BE INVESTIGATED. ALTHOUGH THE SET WAS NOT HANDLED FURTHER, THE CUSTOMER¿S PHOTO WAS EVALUATED AND THE REPORTED EVENT OF BROKEN SPIKE WAS CONFIRMED BY PHOTO AT THE LOCATION OF THE DRIP CHAMBER. THE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    THE SET WAS RECEIVED AS AN UNEXPECTED RETURN WITH A NOTE STATING THAT THERE WAS A BROKEN SPIKE ON A LIPID INFUSION ON A FILTER SET. THERE WAS NO REPORT OF PATIENT HARM.

    Description of Event or Problem · 0

    THE SET WAS RECEIVED AS AN UNEXPECTED RETURN WITH A NOTE STATING THAT THERE WAS A BROKEN SPIKE ON A LIPID INFUSION ON A FILTER SET. THERE WAS NO REPORT OF PATIENT HARM.

    Additional Manufacturer Narrative · 1

    UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED COMPLAINT. TESTING WAS NOT PERFORMED AS THE POTENTIALLY (B)(6) CONTAMINATED EXTENSION SETS WERE DISCARDED TO ELIMINATE THE RISK OF EXPOSURE. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED. CONCOMITANT MEDICAL PRODUCTS: SYRINGE, LOT: 3131765, EXP: 10/01/2019. Z FLUSH 10ML SYRINGE NORMAL SALINE 0.9% ONLY 5ML FILLED WITH BONDED MAXZERO EXT ATTACHED TO MAXPLUS TRIFUSE WITH A MAXZERO ATTACHED, 1.2 FILTER EXT AND MINI FILTER EXT. THERAPY DATE: UNK.

    Description of Event or Problem · 1

    UNEXPECTED RETURN- BROKEN SPIKE, LIPID INFUSION WITH FILTER SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900997 ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1