BEUDAMED
    FDA Adverse Event Other Summary report: N

    AMBIT CONTINUOUS PUMP

    MDR report key: 1002948 · Received February 6, 2008

    Report

    Report Number
    1722214-2008-00003
    Event Type
    Other
    Date Received
    February 6, 2008
    Date of Event
    January 9, 2008
    Report Date
    January 30, 2008
    Manufacturer
    SORENSON MEDICAL PRODUCTS
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE EVALUATION: AMBIT CONTINUOUS PUMP WAS RETURNED IN A CARRYING POUCH. THE POUCH HAS WHITE CONTAMINATION INSIDE AND OUTSIDE OF POUCH. THERE IS NO VISIBLE SIGN THAT FLUID LEAKED ON OR INTO THE PUMP. NO FLUID BAG OR CASSETTE WAS RETURNED FOR THE EVALUATION. THE PUMP OPERATED WITHIN THE MANUFACTURING SPECIFICATION. THE REVIEW OF THE DEVICE HISTORY RECORDS AND THE TREND ANALYSIS INDICATES THAT THE REPORTED CONDITION IS NOT A SYSTEMIC PROBLEM WITH THIS LOT.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT/PRODUCT PROBLEM: DISTRIBUTOR STATED THAT CHEMO LEAKED ONTO A PATIENT'S MATTRESS. DISTRIBUTOR STATED THAT THE NURSE TOLD HIM THE SPIKE CAME OUT OF THE INFUSION BAG AND THAT THE SPIKE WAS NOT INSERTED ALL THE WAY OR CORRECTLY INTO THE INFUSION BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMBIT CONTINUOUS PUMP AMBIT CONTINUOUS PUMP FRN SORENSON MEDICAL PRODUCTS CONTINUOUS PUMP 606050

    Patients

    Seq Age Sex Outcome Treatment
    1