BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 1823120 · Received September 1, 2010

    Report

    Report Number
    6000001-2010-02931
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    June 15, 2010
    Report Date
    June 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION WAS CONFIRMED BUT NOT DUPLICATED. THE ASSIGANBLE CAUSE HAS BEEN DETERMINED TO BE FAULTY MICRO SWITCH FOR THE OCCLUSION ALARM. THE MICRO SWITCH HAS BEEN REPLACED.A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A INFUSOR PUMP WITH A CONDITION OF "MICRO SWITCH FOR THE OCCLUSSION ALARM IS BROKEN'. THIS CONDITION OCCURRED DURING PROGRAMMING/SETUP. THE AREA WHERE THIS EVENT OCCURRED IS SURGERY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.A BAXTER SERVICE TECHNICIAN REPORTED FINDING A INFUSOR PUMP WITH "CONSTANT OCCLUSION ALARM". THIS EVENT OCCURRED DURING PRODUCT EVALUATION. 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