BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2123035 · Received June 8, 2011

    Report

    Report Number
    2016493-2011-00363
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 10, 2011
    Manufacturer
    CAREFUSION CORPORATON
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4) 2011. (B)(4). THE DEVICE AND TUBING HAVE BEEN REC'D, BUT THE FAILURE INVESTIGATION IS NOT COMPLETED. A F/U REPORT WILL BE SUBMITTED WITH THE FAILURE INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PUMPING SEGMENT FUSED DURING AN INFUSION OF DOPAMINE ON A NEURO ICU PT AND THE PUMP DID NOT ALARM. CUSTOMER STATED DOPAMINE IS USUALLY PREPARED BY PHARMACY, BUT RECENTLY THEY HAVE BEEN PURCHASING PREMIXED DOPAMINE. THE PT REQUIRED AN ADD'L MEDICATION TO INCREASE THE BLOOD PRESSURE DUE TO THE FUSED TUBING ON THE DOPAMINE INFUSION. NO LONG TERM PT HARM WAS REPORTED. NO FURTHER EVENT OR PT INFO WAS PROVIDED. CUSTOMER REPORTED THAT THE PC UNIT WAS NOT SEQUESTERED, THEREFORE, NO PC UNIT EVENT LOGS WERE AVAILABLE FOR THE EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORPORATON 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention ALARIS PC UNIT ADMIN SET: 2420-0500, LOT# 10116148| ALARIS PC UNIT: S/N (B)(4)| 400MG DOPAMINE| HYDROCHLORIDE| ALARIS PC UNIT ADMIN SET: 2420-0500, LOT # UNK| 250ML IV BAG| 5% DEXTROSE INJECTION USP (1600 MCG/ML)| LOT P261370, EXP: JUN 12