BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLM A+PMP W/BSE MOD

    MDR report key: 4602578 · Received March 6, 2015

    Report

    Report Number
    9615050-2015-00557
    Event Type
    Malfunction
    Date Received
    March 6, 2015
    Date of Event
    February 17, 2015
    Report Date
    February 17, 2015
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 AN OVER DELIVERY. AT 0630 THE DEVICE WAS PROGRAMMED TO DELIVER INSULIN (100 UNITS/100ML NORMAL SALINE) AT A RATE OF 3 UNITS/HOUR WITH AN UNSPECIFIED VOLUME TO BE INFUSED AND THE DELIVERY WAS STARTED. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT WAS RECEIVING AMIODARONE (0.5MG/MIN) AND DOBUTAMINE (3MCG/KG/MIN) IN D5W AT AN UNSPECIFIED RATE. AT 0645, IT WAS REPORTED THAT THE DEVICE BEGAN TO ALARM WITH AN UNSPECIFIED ALARM CONDITION. WHEN THE NURSE WENT INTO THE ROOM, IT WAS REPORTED THAT THE DEVICE WAS GOING INTO A RAPID RATE. WHEN THE NURSE ATTEMPTED TO STOP THE INFUSION USING THE STOP BUTTON, THE DEVICE KEYPAD DID NOT RESPOND SO SHE HAD TO DISCONNECT THE TUBING FROM THE PATIENT. THE NURSE REPORTED THAT APPROXIMATELY 50ML OF THE INSULIN SOLUTION WAS INFUSED INTO PATIENT. ADDITIONALLY, IT WAS REPORTED THAT A DOWNWARD TREND WAS NOTED IN THE PATIENT'S BLOOD SUGAR LEVELS. AT 0600, THE PATIENT'S BLOOD SUGAR WAS 198. AT 0719 THE PATIENT'S BLOOD SUGAR WAS 152. AT THIS TIME, IT WAS REPORTED THAT THE NURSE GAVE THE PATIENT "A LITTLE PUSH" OF D50W. AT 0804 THE PATIENT'S BLOOD SUGAR WAS 134 AND AT 0903 IT WAS 159. THE PATIENT'S BLOOD SUGAR WAS CAREFULLY MONITORED AND THE PATIENT DID NOT REQUIRE A PROLONGED STAY IN THE HOSPITAL DUE TO THIS EVENT. THE DEVICE WAS REMOVED FROM CLINICAL SERVICE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156333 PLM A+PMP W/BSE MOD 80FRN FRN HOSPIRA COSTA RICA LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR