BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10097815 · Received May 28, 2020

    Report

    Report Number
    2016493-2020-01184
    Event Type
    Injury
    Date Received
    May 28, 2020
    Date of Event
    February 1, 2020
    Report Date
    May 11, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 0

    CORRECTION: B1, B5, H1, H6. ADDITIONAL INFORMATION PROVIDED: B2.

    Description of Event or Problem · 0

    RECEIVED A COPY OF THE CUSTOMER'S MEDSUN REPORT FROM FDA WHICH STATES, ¿ALTEPLACE CONCENTRATION WAS PROGRAMMED INCORRECTLY. THE BAG THAT WAS HANGING WAS 20MG IN 1000 ML. THE ORDERED DOSE WAS 1 MG/HR AT 50 ML/HR. WHAT WAS PROGRAMMED ON THE PUMP WAS 1 MG/HR AT IML/HR. THE SET UP WAS WRONG AT 1 MG/ ML WHEN IT SHOULD HAVE BEEN 20 ML M 1000 ML. AT BEDSIDE REPORT IT WAS NOTICED TO BE WRONG AND CHANGED. DOC WITH PHARMACY NOTIFIED. CONTACTING VIC THAT IS A MED ERROR SPECIALIST WITH PHARM. WAITING TO HEAR BACK. IT APPEARS THAT THE PUMP WAS TURNED OFF IN THE OR AND TURNED BACK ON BY ANESTHESIA DOCTOR. PHARMACIST BELIEVES THAT IT WAS PROGRAMMED CORRECTLY YESTERDAY. MEDSUN COMPLETED BECAUSE "LLL" IS NOT A VISUAL CUE TO ALERT NURSING STAFF ON SUBTHERAPEUTIC DOSING OF CONTINUOUS DRIPS." THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 0

    RECEIVED A COPY OF THE CUSTOMER'S MEDSUN REPORT FROM FDA WHICH STATES, ¿ALTEPLACE CONCENTRATION WAS PROGRAMMED INCORRECTLY. THE BAG THAT WAS HANGING WAS 20MG IN 1000 ML. THE ORDERED DOSE WAS 1 MG/HR AT 50 ML/HR. WHAT WAS PROGRAMMED ON THE PUMP WAS 1 MG/HR AT IML/HR. THE SET UP WAS WRONG AT 1 MG/ ML WHEN IT SHOULD HAVE BEEN 20 ML M 1000 ML. AT BEDSIDE REPORT IT WAS NOTICED TO BE WRONG AND CHANGED. DOC WITH PHARMACY NOTIFIED. CONTACTING VIC THAT IS A MED ERROR SPECIALIST WITH PHARM. WAITING TO HEAR BACK. IT APPEARS THAT THE PUMP WAS TURNED OFF IN THE OR AND TURNED BACK ON BY ANESTHESIA DOCTOR. PHARMACIST BELIEVES THAT IT WAS PROGRAMMED CORRECTLY YESTERDAY. MEDSUN COMPLETED BECAUSE "LLL" IS NOT A VISUAL CUE TO ALERT NURSING STAFF ON SUBTHERAPEUTIC DOSING OF CONTINUOUS DRIPS." CUSTOMER CHECKED OFF ADVERSE EVENT ON MEDSUN REPORT FROM THE FDA. NO FURTHER INFORMATION OF THE PATIENT IMPACT WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    RECEIVED A COPY OF THE CUSTOMER'S MEDSUN REPORT FROM FDA WHICH STATES, ¿ALTEPLACE CONCENTRATION WAS PROGRAMMED INCORRECTLY. THE BAG THAT WAS HANGING WAS 20 MG IN 1000 ML. THE ORDERED DOSE WAS 1 MG/HR AT 50 ML/HR. WHAT WAS PROGRAMMED ON THE PUMP WAS 1 MG/HR AT IML/HR. THE SET UP WAS WRONG AT 1 MG/ ML WHEN IT SHOULD HAVE BEEN 20 ML M 1000 ML. AT BEDSIDE REPORT IT WAS NOTICED TO BE WRONG AND CHANGED. DOC WITH PHARMACY NOTIFIED. CONTACTING VIC THAT IS A MED ERROR SPECIALIST WITH PHARM. WAITING TO HEAR BACK. IT APPEARS THAT THE PUMP WAS TURNED OFF IN THE OPERATING ROOM AND TURNED BACK ON BY ANESTHESIA DOCTOR. PHARMACIST BELIEVES THAT IT WAS PROGRAMMED CORRECTLY YESTERDAY. MEDSUN COMPLETED BECAUSE "LLL" IS NOT A VISUAL CUE TO ALERT NURSING STAFF ON SUBTHERAPEUTIC DOSING OF CONTINUOUS DRIPS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561027 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other PRI TUBING, THERAPY DATE 02/01/2020