BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 9193535 · Received October 15, 2019

    Report

    Report Number
    9616066-2019-02873
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Report Date
    September 19, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    07613203021012
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT THAT THE TUBING SET¿S MALE LUER CRACKED/BROKE OFF WHEN TIGHTLY CONNECTING TO AN EXTENSION SET WAS NOT CONFIRMED. THE SETS WERE VISUALLY INSPECTED FOR KINKS, INCOMPLETE BONDING ENGAGEMENTS, HOLES/TEARS IN THE TUBING OR DAMAGES TO THE COMPONENTS. VISUAL INSPECTION OF THE SET NOTED NO DAMAGE OR ANY ANOMALIES. FUNCTIONAL AND PRESSURE TESTING RESULTED IN NO LEAKING. THE FEMALE AND MALE LUER PORTS WERE MEASURED AND FOUND TO BE WITHIN ISO STANDARDS. THE ROOT CAUSE OF CUSTOMER¿S REPORT WAS NOT IDENTIFIED BECAUSE THE SETS PRIMED AND INFUSED COMPLETELY WITHOUT ANY ISSUES OR SIGNS OF DAMAGES WHEN CONNECTING MATING COMPONENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TUBING SET MALE LUER CRACKED/BREAKING OFF WHEN TIGHTLY SEALED/CONNECTED TO THE PERIPHERAL EXTENSION TUBING SET. PENDING THE CLINICAL SETTING, THE TUBING SET IS EITHER ATTACHED TO AN EXTENSION SET OR A T-CONNECTOR WITH A MAXZERO ATTACHED TO THE FEMALE HUB. THE CUSTOMER FURTHER STATED THAT THERE HAVE BEEN NO ADVERSE EFFECTS CAUSED TO ANY PATIENTS FROM THE EVENTS.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: B BRAUN SMALLBORE T-PORT EXTENSION SET, LOT: 0061577531, EXP: 2022-07-31; CARESITE EXTENSION SET, LOT: 0061676252, EXP: 2022-04-30; DUAL CAP ALCOHOL CAPS, LOT: A002274, EXP: 2020-09; DUAL CAP ALCOHOL CAPS, LOT: A002875, EXP: 2021-05, THERAPY DATE UNK. THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUBING SET MALE LUER CRACKED/BREAKING OFF WHEN TIGHTLY SEALED/CONNECTED TO THE PERIPHERAL EXTENSION TUBING SET. PENDING THE CLINICAL SETTING, THE TUBING SET IS EITHER ATTACHED TO AN EXTENSION SET OR A T-CONNECTOR WITH A MAXZERO ATTACHED TO THE FEMALE HUB. THE CUSTOMER FURTHER STATED THAT THERE HAVE BEEN NO ADVERSE EFFECTS CAUSED TO ANY PATIENT'S FROM THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    986980 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 2420-0007 19056902 07613203021012

    Patients

    Seq Age Sex Outcome Treatment
    1 8100, 8015, MZ1000-07, MZ9267, TD UNK