BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS50 INFUSION PUMP

    MDR report key: 1853177 · Received October 5, 2010

    Report

    Report Number
    6000001-2010-03732
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K945942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT'S AGE AT THE TIME OF THE EVENT HAS BEEN PROVIDED IN THIS FOLLOW-UP MEDWATCH REPORT. THE NURSE STATED THAT THE PUMP DELIVERED BREAST MILK AND DID NOT DELIVER AN INTRAVENOUS DRUG OR BAXTER PRODUCT.

    Additional Manufacturer Narrative · 1

    (B)(4). A SERVICE HISTORY REVIEW WAS PERFORMED REVEALING THIS PUMP HAS NEVER PREVIOUSLY BEEN SENT TO BAXTER FOR SERVICE AND, THEREFORE, THE REPORTED CONDITION IS NOT RELATED TO ANY PREVIOUS REPORTED PROBLEM FOR THIS PUMP. A DEVICE HISTORY REVIEW WAS ALSO PERFORMED, FINDING THE BARREL CLAMP ASSEMBLY NEEDED TO BE CHANGED DUE TO A PURGE OF THE ACTUATOR SUPPORT DURING THE MANUFACTURING OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE SENT BACK TO BAXTER FOR EVALUATION. THE FACILITY REPAIRED THE DEVICE BY REPLACING THE BARREL CLAMP. AFTER THE REPAIR, THE DEVICE IS FULLY FUNCTIONAL. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED AN AS50 INFUSION PUMP THAT WAS TO FEED AN INFANT 21CC OVER 2 HOURS. WHEN THE INFUSION WAS CHECKED, IT WAS NOTICED THAT ONLY 8CC HAD BEEN DELIVERED. THE DEVICE WAS REMOVED AND SENT TO THE FACILITY'S BIOMEDICAL DEPARTMENT FOR EVALUATION. A REVIEW OF THE EVENT HISTORY DETERMINED THAT A CHECK BARREL - ALERT WAS RECEIVED DURING THE INFUSION, CAUSING THE INTERRUPTION OF DELIVERY. PATIENT GLUCOSE WAS GREATER THAN 100 WITH NO RESIDUAL AND GIRTH DECREASE OF 1 CM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AS50 INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO