BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPUMP

    MDR report key: 3031593 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08172
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K052973
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS SERVICED ON-SITE BY A FIELD SERVICE TECHNICIAN. THIS IS AN ANCILLARY SERVICE EVENT OPENED DURING INVESTIGATION OF (B)(4). THE ROOT CAUSE OF THE LOOSE MOTOR IS UNKNOWN. CONCLUSION CODE 19 WAS SELECTED BECAUSE THIS IS THE MOST APPLICABLE CODE TO THE PROBLEM. THE PROBLEM WAS CONFIRMED. HOWEVER, THE PROBLEM CANNOT CONCLUSIVELY BE ASSIGNED TO A HUMAN FACTORS ISSUE. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING PRODUCT EVALUATION BY A BAXTER SERVICE TECHNICIAN, AN I-PUMP INFUSION PUMP WAS FOUND TO HAVE A LOOSE MOTOR. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133957 IPUMP PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1