BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSO.R.

    MDR report key: 2221318 · Received August 24, 2011

    Report

    Report Number
    6000001-2011-20477
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED MALFUNCTION OF AN INFUSO.R. PUMP WHICH WOULD NOT BOLUS DUE TO AN INOPERABLE SWITCH BOARD WAS CONFIRMED AND REPRODUCED. THE ROOT CAUSE WAS ATTRIBUTED TO A DEFECTIVE PRINTED CIRCUIT BOARD SWITCH. THE SWITCHBOARD WAS REPLACED TO FIX THE PROBLEM. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    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.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN INFUSO.R. PUMP WHICH WOULD NOT BOLUS DUE TO AN INOPERABLE SWITCH BOARD. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT DELIVERY. THE PROCESS STEP IS UNKNOWN. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT, PATIENT INJURY, OR MEDICAL INTERVENTION ACCORDING TO THE HOSPITAL REPRESENTATIVE. 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