BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XLD 110V L.A. REF

    MDR report key: 3912716 · Received May 14, 2014

    Report

    Report Number
    9615050-2014-03403
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 13, 2014
    Report Date
    April 15, 2014
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K010924
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE TECHNOLOGY OF THE PLUM XLD LIST #(B)(4) 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 INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPITAL PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED MORE MEDICATION THAN INTENDED. AT 1118, THE DEVICE WAS PROGRAMMED TO DELIVER IMMUNOGLOBULIN H, AT A RATE OF 50ML/HR, WITH A VTBI (VOLUME TO BE INFUSED) OF 300ML, FOR A DURATION OF 5 HRS AND THE DELIVERY WAS STARTED. IT WAS REPORTED THE PT'S FAMILY TOLD THE NURSE THAT THE DELIVERY COMPLETED IN 4 HRS INSTEAD OF THE INTENDED 6 HRS AS PROGRAMMED. THE CUSTOMER CONTACT REPORTED THE PT EXPERIENCED A HEADACHE FOLLOWING THE DELIVERY AND RECEIVED AN UNSPECIFIED CONCENTRATION OF METAMIZOLE AND ACETAMINOPHEN. THE DEVICE WAS REMOVED FROM CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288044 XLD 110V L.A. REF 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR