BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSO.R.

    MDR report key: 2883571 · Received December 21, 2012

    Report

    Report Number
    1416980-2012-07930
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K883577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE CUSTOMER REPORTED PROBLEM OF "WHERE YOU PUT THE SYRINGE THE PLASTIC PIECE IS BROKEN OFF' WAS CONFIRMED DURING DEVICE EVALUATION. THE CAUSE OF THE PROBLEM WAS BROKEN PUSHER BLOCK ASSEMBLY. NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPORTED AN INFUSOR PUMP WITH "WHERE YOU PUT THE SYRINGE THE PLASTIC PIECE IS BROKEN OFF". THE PROCESS STEP FOR THIS EVENT IS UNKNOWN. HOWEVER, IT IS KNOWN TO HAVE OCCURRED IN THE "OR" DEPARTMENT. THERE WAS NO PATIENT INVOLVEMENT, PATIENT/USER INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1