BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 9338792 · Received November 18, 2019

    Report

    Report Number
    9616066-2019-03312
    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 GRIP REVISED-SUSPECT CHANGED FROM CAD NFV TO CAD SYR TUBE ADDITIONAL INFORMATION ADDED TO: B7, & D4. CORRECTION; H.6. PATIENT CODE). THE CUSTOMER REPORT THAT THE BONDED TEXIUM SYRINGES BROKE AND LEAKED WAS NOT CONFIRMED AS THE REPORTED PRODUCT WAS NOT RECEIVED FOR EVALUATION. NO INVESTIGATION WAS ABLE TO BE PERFORMED AS NO PRODUCT WAS RECEIVED. THE CUSTOMER REPORTED THAT OVER THE LAST COUPLE OF MONTHS THEY EXPERIENCED ISSUES WITH THE BONDED TEXIUM SYRINGES BREAKING AND LEAKING BETWEEN THE TEXIUM AND THE SYRINGE. THE ROOT CAUSE WAS NOT IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE FACILITY¿S PHARMACIST THAT OVER THE LAST COUPLE OF MONTHS THEY EXPERIENCED ISSUES WITH THE BONDED TEXIUM SYRINGES BREAKING AND LEAKING BETWEEN THE TEXIUM AND THE SYRINGE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITY¿S PHARMACIST THAT OVER THE LAST COUPLE OF MONTHS THEY EXPERIENCED ISSUES WITH THE BONDED TEXIUM SYRINGES BREAKING AND LEAKING BETWEEN THE TEXIUM AND THE SYRINGE. ALTHOUGH REQUESTED NO FURTHER EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1129754 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INFUSION FPA CAREFUSION CAD SYR TUBE

    Patients

    Seq Age Sex Outcome Treatment
    1