BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AS50 INFUSION PUMP

    MDR report key: 1821909 · Received August 31, 2010

    Report

    Report Number
    6000001-2010-02906
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K945942
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR ADDITIONAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS NOT CONFIRMED AND NOT DUPLICATED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. THE DEVICE WAS RETURNED UNREPAIRED AT THE CUSTOMER'S REQUEST. ADDITIONAL: A SERVICE HISTORY REVIEW HAS BEEN PERFORMED AND THE DEVICE HAS NOT BEEN SERVICED BY BAXTER PRIOR TO THIS EVENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED CONDITION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING SERVICE AT BAXTER IT WAS DISCOVERED THAT AN AS50 INFUSION PUMP WITH 'CHECK FLANGE ALARM RECEIVED DURING INITIAL RUN'. THIS EVENT OCCURRED DURING PRODUCT EVALUATION. THERE WAS AN INTERRUPTION OF DELIVERY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. 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