BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM A+ TRIPLE NEW 8

    MDR report key: 1940432 · Received December 20, 2010

    Report

    Report Number
    2921482-2010-01014
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 30, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PATIENT RECEIVED MORE MEDICATION THAN INTENDED. AT 1000, LINE A OF CHANNEL 2 WAS PROGRAMMED TO DELIVER AN UNSPECIFIED CONCENTRATION OF OXALIPLATIN, AT A RATE OF 132 ML/HR, A VTBI (VOLUME TO BE INFUSED) OF 530 ML, FOR A DURATION OF 4 HOURS, AND THE DELIVERY WAS STARTED. NO FURTHER PROGRAMMED PARAMETERS WERE PROVIDED. AT 1130, THE DEVICE SOUNDED AN UNSPECIFIED AUDIBLE ALARM. AT THIS TIME, THE NURSE NOTED THE 530 ML DELIVERY WAS COMPLETE. THE PHYSICIAN WAS NOTIFIED. THE PATIENT WAS OBSERVED FOR 45 MINUTES "WITH IV OF NORMAL SALINE INFUSING." THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+ TRIPLE NEW 8 80FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention