BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2213639 · Received August 16, 2011

    Report

    Report Number
    6000001-2011-19225
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    March 3, 2011
    Report Date
    July 26, 2011
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT CODE OF THIS DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. A SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO THE FOOD AND DRUG ADMINISTRATION (FDA) IN WHICH THE FDA THEN REPORTED TO BAXTER PRODUCT SURVEILLANCE OF AN INCIDENT IN WHICH A PATIENT WAS RECEIVING AN INFUSION OF CHEMOTHERAPY WHEN HER HUSBAND SOUGHT ASSISTANCE FROM NURSE. THE HUSBAND STATED THAT THERE WAS A POOL OF LIQUID ON THE FLOOR. NURSE INVESTIGATED AND FOUND A 4 FOOT BY 1 FOOT AREA OF BLOOD AND CHEMO SOLUTION (CHEMOTHERAPY WITH OXALIPLATIN AND LEUCOVORIN) ON THE FLOOR WHICH HAD APPARENTLY DRIPPED DOWN FROM AN UNKNOWN CONTINUFLO IV TUBING ONTO THE PATIENT'S SWEATER, DOWN THE SIDE OF THE CHAIR AND ONTO THE FLOOR. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA

    Patients

    Seq Age Sex Outcome Treatment
    1 CHEMOTHERAPY WITH OXALIPLATIN AND LEUCOVORIN