BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2945431 · Received February 6, 2013

    Report

    Report Number
    1416980-2013-03021
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FRN
    PMA / PMN Number
    K880733
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING VISUAL INSPECTION IT WAS OBSERVED THAT THE SNAP ON DISK WAS BROKEN. THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS OBTAINED FROM THE CUSTOMER. THERE WAS BREAKAGE OR CRACKING AT BOTH ENDS OF THE IV SET. THE SYRINGES BEING USED STICK TO THE IV SETS LUER UPON DISCONNECTION. THE NURSES TWIST THE STUCK SYRINGE FROM THE IV SET, RESULTING IN THE STEM BREAKING. EVALUATION INFORMATION: AFTER FURTHER INVESTIGATION A CAUSE OF THE REPORTED CONDITION COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A NURSE HAD CONTACTED HOME CARE SERVICES (HCS) REGARDING A PATIENT CONTROL ANALGESIA (PCA) EXTENSION SET WHICH HAD NUMEROUS EXTENSION SETS COME APART AND BREAK. THERE WAS NO PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49901 ACCESS PUMP, INFUSION FRN BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1