BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUMSET CLAVE YSITE 104IN NDEHP

    MDR report key: 2890694 · Received December 26, 2012

    Report

    Report Number
    9615050-2012-01585
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    November 28, 2012
    Report Date
    November 29, 2012
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K101677
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE PT RECEIVED MORE MEDICATION THAN INTENDED. THE CUSTOMER CONTACT REPORTED THE PRIMARY TUBING SET WAS TO BE USED TO DELIVER INSULIN. THE CUSTOMER CONTACT INDICATED THAT THE TUBING SET WAS PRIMED USING THE WHITE FLOW REGULATOR ON THE CASSETTE. THE PRIMED SET WAS THEN INSERTED INTO CHANNEL 1 OF A PLUM PUMP. BETWEEN 1200 AND 1230, LINE A ON CHANNEL 1 OF THE PUMP WAS PROGRAMMED TO DELIVER INSULIN 100 U/ML, AT A RATE OF 8ML/HR, WITH A VOLUME TO BE INFUSED (VTBI) OF 100ML, FOR A DURATION BETWEEN 23-24 HOURS, AND THE DELIVERY WAS STARTED. AFTER APPROXIMATELY 7 MINUTES, THE CUSTOMER CONTACT REPORTED THAT WHEN THE NURSE RETURNED TO THE PT'S BEDSIDE, THE NURSE NOTED THAT THE INSULIN SOLUTION CONTAINER WAS EMPTY. AT THIS TIME, IT WAS REPORTED THAT THE NURSE CHECKED THE SET-UP, OPENED THE CASSETTE DOOR OF THE PUMP, AND NOTED THAT THE FLOW REGULATOR OF THE CASSETTE OF THE TUBING SET WAS MISSING. THE PHYSICIAN WAS NOTIFIED. AT AN UNSPECIFIED TIME, THE PT'S BLOOD SUGAR LEVEL WAS CHECKED. THE CUSTOMER CONTACT REPORTED THAT THE PT'S LOWEST BLOOD GLUCOSE VALUE WAS "AROUND 100." AT APPROXIMATELY 1235, THE PT WAS TREATED WITH UNSPECIFIED VOLUME OF 10% DEXTROSE, ONE AMPOULE OF 50% DEXTROSE AND AN UNSPECIFIED CONCENTRATION OF GLUCAGON. THE CUSTOMER CONTACT INDICATED THE PT WAS GIVEN AN UNSPECIFIED AMOUNT OF ORANGE JUICE. IT WAS REPORTED THAT THE PT'S BLOOD GLUCOSE WAS MEASURED EVERY 30 MINUTES FOR AN UNSPECIFIED LENGTH OF TIME, WITH RESULTS REPORTED AS RANGING FROM 274-363 MG/DL. THE CUSTOMER CONTACT REPORTED THAT THE PT RESPONDED WELL TO TREATMENT. THE DEVICE AND TUBING SET WERE REMOVED FROM CLINICAL SERVICE. THERAPY WAS RESUMED USING A REPLACEMENT DEVICE AND TUBING SET. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLUMSET CLAVE YSITE 104IN NDEHP 80FPA FPA HOSPIRA COSTA RICA LTD. NA 131745H

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention PLUM PUMP: LIST #20678, SN (B)(4)