BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 9337461 · Received November 18, 2019

    Report

    Report Number
    9616066-2019-03309
    Event Type
    Malfunction
    Date Received
    November 18, 2019
    Date of Event
    October 3, 2019
    Report Date
    October 28, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT GRID REVISED-SUSPECT CHANGED FROM CAD NFV TO CAD_SYR_TUBE. THE CUSTOMER REPORT THAT THE BONDED TEXIUM SYRINGE LEAKED WAS NOT CONFIRMED. ALTHOUGH THE CUSTOMER PROVIDED PHOTO SHOWS A USED BROKEN TEXIUM 60ML SYRINGE WITH THE BREAKAGE OBSERVED AS PART OF ITS "COLLAR" BROKEN OFF AND THE BROKEN OFF "COLLAR" PIECE STILL AFFIXED ONTO ITS TEXIUM CONNECTOR, NO INVESTIGATION WAS ABLE TO BE PERFORMED AS THE CUSTOMER DID NOT SEQUESTER THE PRODUCT. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BONDED TEXIUM SYRINGE LEAKED A DRUG BEHIND THE PLUNGER. THE ATTACHED PDF DOCUMENT INDICATES THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT SEQUESTERED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED. REQUESTED PATIENT DEMOGRAPHICS HOWEVER NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BONDED TEXIUM SYRINGE LEAKED DRUG BEHIND THE PLUNGER. ALTHOUGH REQUESTED NO FURTHER EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1130436 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INFUSION FPA CAREFUSION CAD SYR TUBE

    Patients

    Seq Age Sex Outcome Treatment
    1