BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSO.R.

    MDR report key: 2163060 · Received July 15, 2011

    Report

    Report Number
    6000001-2011-12140
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 28, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RETURNED FOR EVALUATION HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED MALFUNCTION OF "PRONGS ARE BROKEN OFF WHERE SYRINGE IS HELD" WAS CONFIRMED AND NOT REPRODUCED. THE ROOT CAUSE WAS ATTRIBUTED TO A DAMAGED SYRINGE HOLDER. THE SYRINGE HOLDER WAS REPLACED TO FIX THE PROBLEM. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN INFUSO.R. PUMP WITH A CONDITION OF "PRONGS ARE BROKEN OFF WHERE SYRINGE IS HELD." THIS CONDITION OCCURRED DURING PROGRAMMING/SETUP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO PATIENT INVOLVEMENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSO.R. PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1