BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XLD 110V L.A. REF

    MDR report key: 3931460 · Received June 27, 2014

    Report

    Report Number
    9615050-2014-04218
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE TECHNOLOGY OF THE PLUM XLM LIST #11859 DOES NOT CONTAIN A PUMP HISTORY THAT PROVIDES PAST PROGRAMMED SETTINGS. HOSPIRA IS UNABLE TO CONFIRM THE PROGRAMMING OF THE DEVICE REPORTED BY THE CUSTOMER. THIS REPORT REPRESENTS ALL INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    REPORT 3 OF 3: THE CUSTOMER CONTACT REPORTED THAT THE DEVICE DELIVERED MORE THAN INTENDED. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE NEONATAL INTENSIVE CARE UNIT ON AN UNSPECIFIED DATE. AT 0400, THE DEVICE WAS PROGRAMMED TO DELIVER AN UNSPECIFIED 10% GLUCOSE SOLUTION AT A RATE OF 4.6 ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 9.2 ML, FOR A DURATION OF 2 HOURS, AND THE DELIVERY WAS STARTED. IT WAS REPORTED THAT 20 MINUTES LATER, THE NURSE NOTED THAT THE DELIVERY WAS COMPLETE. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THE CUSTOMER CONTACT REPORTED THAT THE PATIENT'S BLOOD GLUCOSE WAS DRAWN AND IT RESULTED AT 230 MG/DL. NO PRE-EVENT BLOOD GLUCOSE VALUES WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THAT THE PATIENT WAS TREATED WITH AN UNSPECIFIED CONCENTRATION OF SALINE SOLUTION USING A REPLACEMENT DEVICE. NO PROGRAMMING PARAMETERS WERE PROVIDED. THE CUSTOMER CONTACT REPORTED THAT AFTER AN UNSPECIFIED AMOUNT OF TIME, THE PATIENT'S BLOOD GLUCOSE LEVEL HAD DECREASED TO 184 MG/DL. IT WAS REPORTED THAT AT 0700, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS 134 MG/DL. THE CUSTOMER CONTACT REPORTED THAT THE PATIENT'S CONDITION WAS IMPROVING. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375981 XLD 110V L.A. REF 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 DA Life Threatening| R GLUCOSE SOLUTION 10%, MANUFACTURER UNK