BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYMBIQ SINGLE CHANNE

    MDR report key: 1950148 · Received December 9, 2010

    Report

    Report Number
    2921482-2010-00974
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 15, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K041550
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN REC'D. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT REC'D MORE MEDICATION THAN INTENDED. ON AN UNSPECIFIED DATE AND TIME, THE DEVICE WAS PROGRAMMED FOR PRIMARY DELIVERY OF 0.9% SODIUM CHLORIDE AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. ON (B)(6) 2010, AT 1500, THE DEVICE WAS PROGRAMMED FOR PIGGYBACK DELIVERY OF ZOSYN 3.375GRAMS/50ML FOR A DURATION OF 30 MINUTES. NO FURTHER PROGRAMMING PARAMETERS WERE PROVIDED. IT WAS REPORTED THAT 5 MINUTES AFTER THE DELIVERY WAS STARTED, THE PIGGYBACK DELIVERY WAS COMPLETE. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE. THE PHYSICIAN WAS NOTIFIED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMBIQ SINGLE CHANNE 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1