BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE

    MDR report key: 3941486 · Received April 16, 2014

    Report

    Report Number
    2016493-2014-00206
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 1, 2014
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PT INFO REQUESTED AND ALL AVAILABLE INFO IS INCLUDED IN SECTIONS A AND B. ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PT DID NOT RECEIVE MEDICATION FOR 19 HRS. THE DEVICE READ 19.4MLS INFUSED BUT THE SYRINGE STILL HAD 19.4MLS IN IT. THIS WAS NOTICED WHEN THE DEVICE TURNED OFF BY ITSELF AND A "CALIBRATE" ALARM OCCURRED AND THE NURSE OPENED THE SYRINGE CHAMBER DOOR AND NOTICED THAT 19.4 MLS WERE STILL REMAINING IN THE SYRINGE. THERE WAS NO REPORT OF PT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232581 ALARIS PCA MODULE FPA CAREFUSION CORP 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN UNK, PCA ADMIN SET,| MFR/MODEL/LOT UNK