BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MD - DISPOSABLE

    MDR report key: 2012470 · Received March 9, 2011

    Report

    Report Number
    6000001-2011-01744
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 15, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. THE DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE OF A NO FLOW CONDITION THAT OCCURRED WITH AN UNKNOWN BAXTER SET, PRODUCT CODE UNKNOWN (EITHER 2C8519 OR 2C8541), LOT NUMBER UNKNOWN. A SIGMA PUMP WAS USED. THE CUSTOMER PRIMED THE PRIMARY AND STARTED INFUSING AN UNKNOWN MEDICATION. THE PRIMARY WAS THEN LOWERED USING A FULLY EXTENDED HANGER FROM AN UNKNOWN SECONDARY SET. THE SECONDARY WAS CONNECTED AND THE UNKNOWN MEDICATION WOULD NOT FLOW. THE PRIMARY WAS THEN LOWERED EVEN MORE USING TWO FULLY EXTENDED HANGERS, AND THE SOLUTION WOULD STILL NOT FLOW. THE PRIMARY WAS THEN CLAMPED AND THE SECONDARY BEGAN TO FLOW. IT IS UNKNOWN IF THE PRIMARY WAS STILL LOWERED WITH TWO HANGERS WHEN THE SECONDARY SOLUTION BEGAN TO FLOW. THE CONDITION OCCURRED DURING PATIENT USE. 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 MD - DISPOSABLE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 SIGMA PUMP, UNKNOWN SECONDARY, UNKNOWN MEDS