BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESHIELD SYMBIQ SET WITH 2 CLAVES

    MDR report key: 1180852 · Received September 23, 2008

    Report

    Report Number
    9615050-2008-00279
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 27, 2008
    Manufacturer
    HOSPIRA DE COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACR INDICATED THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED CONCURRENT DELIVERY. THE TUBING SET WAS BEING USED TO DELIVER NORMAL SALINE AT A RATE OF 20ML/HR ON THE PRIMARY LINE VIA SYMBIQ PUMP. AT AN UNSPECIFIED TIME, A SECONDARY TUBING SET WAS CONNECTED TO THE PRIMARY TUBING SET TO DELIVER AN UNSPECIFIED CONCENTRATION OF KEFZOL AT A RATE OF 120ML/HR. THE PRIMARY SOLUTION CONTAINER WAS LOWERED BELOW THE SECONDARY CONTAINER. AT THIS TIME, THE NURSE REPORTED THE PRIMARY AND SECONDARY SOLUTIONS WERE DELIVERING CONCURRENTLY. THE PRIMARY SOLUTION CONTAINER WAS LOWERED FURTHER BELOW THE SECONDARY SOLUTION FLOWED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESHIELD SYMBIQ SET WITH 2 CLAVES 80-FRN FRN HOSPIRA DE COSTA RICA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ADULT LIFESHIELD SECONDARY SET