BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2943834 · Received January 30, 2013

    Report

    Report Number
    2016493-2013-00088
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 8, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THEY REVIEWED ALL THE DATA AND NEED NO FURTHER ASSISTANCE. THE CUSTOMER HAS IMPLEMENTED SEVERAL POLICIES TO REDUCE FUTURE RISKS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVER INFUSION OF DOPAMINE. THE NURSE STARTED A TPN INFUSION. DOPAMINE THAT HAD PREVIOUSLY BEEN INFUSING ON ANOTHER MODULE CONNECTED TO THE SAME PC UNIT BUT WAS NOT IN USE, BUT THE SET HAD NOT BEEN REMOVED FROM THE PUMP. THE NURSE TURNED OFF THE MODULE IN ORDER TO SEND AN AUTO-PROGRAM REQUEST FOR THE TPN AND LEANED ACROSS THE BED TO SCAN THE MEDICATION LABELS AND THE BARCODE LABEL ON THE MODULE. THE NURSE SCANNED THE TPN BAG LABEL, THEN INADVERTENTLY SCANNED THE WRONG MODULE SO THE AUTO-PROGRAM REQUEST FOR THE TPN WAS SENT TO THE MODULE CONTAINING THE DOPAMINE. THE NURSE STARTED THE INFUSION AT THE RATE INTENDED FOR TPN WHICH RESULTED IN DELIVERY OF DOPAMINE AT 182 MCG/KG/MIN. THE PT RAPIDLY BEGAN TO DECOMPENSATE WHEN THE NURSE AND MD REALIZED THE DOPAMINE WAS RUNNING. IN THE POS-INCIDENT ASSESSMENT, THE NURSE STATED THAT SHE HAD NOT CHECKED THE LINES FROM BAG TO PT WHEN SHE AUTO-PROGRAMMED. THE PT NEEDED TO BE INTUBATED AND VENTILATED, AND REQUIRED THE FOLLOWING MEDICATIONS: NITROPRUSSIDE, MILRINONE, AND SODIUM BICARBONATE. THE PT DEVELOPED ANEMIA AND COAGULOPATHIES. THE PT REMAINS IN THE HOSP AND HAS NEUROLOGICAL DEFICITS. THE PT IS NO LONGER VENTILATED. IT IS UNKNOWN AS TO WHETHER THE NEUROLOGICAL DEFICITS ARE BECAUSE OF THE PROFOUND HYPOXIA AT BIRTH OR BECAUSE OF THE INCIDENT. HOWEVER, THERE WERE CHANGES IN THE HEAD ULTRASOUND FROM BASELINE OBTAINED AT BIRTH. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT OR PT INFORMATION PROVIDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41229 ALARIS PUMP MODULE FRN CAREFUSION CORP. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Required Intervention ALARIS PUMP MODULE: SN - UNK| ALARIS PUMP MODULE ADMIN SET: MODEL/LOT - UNK| ALARIS PC UNIT, SN - UNK