BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLUM A+3 PUMP

    MDR report key: 1032956 · Received April 23, 2008

    Report

    Report Number
    2921482-2008-00133
    Event Type
    Other
    Date Received
    April 23, 2008
    Date of Event
    March 23, 2008
    Report Date
    March 28, 2008
    Manufacturer
    HOSPIRA, INC.
    Product Code
    FRN
    PMA / PMN Number
    K024084
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE PASSED TESTING FOR DELIVERY ACCURACY ON CHANNEL 2. THE CUSTOMER CONTACT INDICATED THE EVENT WAS THE RESULT OF AN OPERATOR ERROR IN PROGRAMMING THE DEVICE. THE PUMP HISTORY WAS PRINTED AT THE MFG FACILITY. A REVIEW OF THE PUMP HISTORY INDICATED THAT CHANNEL 2 OF THE PUMP CONTINUED TO BE IN USE AFTER THE REPORTED EVENT DATE. ALL DATA FROM THE REPORTED EVENT DATE OF 2008 WAS OVERWRITTEN BY THE NEWER INFO.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN UNSPECIFIED OPERATOR ERROR IN PROGRAMMING THE PUMP WHICH RESULTED IN THE PT RECEIVING MORE MEDICATION THAN INTENDED. AT 0400, CHANNEL 2 OF THE PUMP WAS PROGRAMMED TO DELIVER 4000 UNITS HEPARIN (25,000 UNITS/250 ML) FOLLOWED BY A CONTINUOUS DELIVERY OF HEPARIN AT 900 UNITS/HR AND THE DELIVERY WAS STARTED. NO SPECIFIC PROGRAMMING PARAMETERS WERE PROVIDED. AT APPROX 0700, THE NURSE NOTED THAT THE SOLUTION BAG WAS "ALMOST EMPTY." IT WAS REPORTED A NEW BAG OF HEPARIN WAS OBTAINED AND THE DELIVERY WAS RESUMED. AT AN UNSPECIFIED TIME, THE PT WAS PROPHYLACTICALLY TREATED WITH 50 MG OF PROTAMINE SULFATE. THE PHYSICIAN REPORTED. "PT IS NOT HAVING ANY SIGNS OF BLEEDING." AT AN UNSPECIFIED TIME, THE PUMP WAS REMOVED FROM CLINICAL SERVICE. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUM A+3 PUMP 80-FRN FRN HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other HEPARIN