BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSO.R.

    MDR report key: 2663309 · Received July 20, 2012

    Report

    Report Number
    6000001-2012-12635
    Event Type
    Malfunction
    Date Received
    July 20, 2012
    Date of Event
    July 2, 2012
    Report Date
    July 3, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION OF SOMETHING LOOSE INSIDE WHILE DOING A GRAVITY CHECK INVOLVING AN INFUSO.R. PUMP WAS CONFIRMED BUT NOT REPRODUCED DURING SAMPLE EVALUATION. THE ASSIGNABLE CAUSE WAS DETERMINED TO BE A DAMAGED SYRINGE END BLOCK. THE SYRINGE END BLOCK WAS REPLACED TO FIX THE REPORTED CONDITION.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN INFUSO.R. PUMP WITH A CONDITION OF 'SOMETHING LOOSE INSIDE WHILE DOING A GRAVITY CHECK.' 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