BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 1871804 · Received October 16, 2010

    Report

    Report Number
    6000001-2010-04088
    Event Type
    Malfunction
    Date Received
    October 16, 2010
    Date of Event
    April 2, 2010
    Report Date
    April 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF THE CONSTANT ALARM WAS CONFIRMED AND DUPLICATED. THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED AT THIS TIME. THIS DEVICE WILL NOT BE REPAIRED AT THIS TIME SINCE IT IS A BAXTER-OWNED UNIT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE EVALUATION IS CURRENTLY IN PROGRESS. A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A INFUSOR PUMP WITH A CONDITION OF "IT ALARMS WHEN IT IS RUNNING". IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. THE AREA WHERE THIS EVENT OCCURRED IS UNKNOWN. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE. A BAXTER SERVICE TECHNICIAN REPORTED A CONSTANT ALARM OCCURRED AFTER PUMP STARTED TO RUN. THIS EVENT OCCURRED DURING PRODUCT EVALUATION. THE CONSTANT ALARM CAUSED AN INTERRUPTION DURING 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 6461500 INFUSOR PUMP (1 LABEL) PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1