BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3122912 · Received May 21, 2013

    Report

    Report Number
    1416980-2013-13072
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 29, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A FREE FLOW OF A NON-BAXTER DRUG USING AN UNKNOWN SECONDARY SET PRIOR TO CONNECTION TO THE PATIENT. THE CUSTOMER REPORTED THAT THE NURSE ATTACHED THE SECONDARY BAG AND TUBING TO THE PRIMARY SET, WHICH WAS LOADED INTO AN UNKNOWN PUMP. THE NURSE THEN PROGRAMMED AND STARTED THE PUMP AND THEN NOTICED THAT THE SECONDARY BAG APPEARED TO BE FREE FLOWING AND SHE CLAMPED THE TUBING. THE NURSE REPLACED THE SECONDARY SET USING THE SAME PUMP AND THE SAME PRIMARY SET AND RESTARTED THE SECONDARY INFUSION WITHOUT ANY FURTHER PROBLEMS. THE NURSE DID NOT NOTICE IF THE INFUSION WAS BACK FLOWING INTO THE PRIMARY CONTAINER AS BOTH SOLUTIONS WERE CLEAR. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223947 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN PUMP| CIPRO