BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE

    MDR report key: 3981490 · Received July 25, 2014

    Report

    Report Number
    2016493-2014-00352
    Event Type
    Injury
    Date Received
    July 25, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 26, 2014
    Manufacturer
    CAREFUSION CORP.
    Product Code
    MEA
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES NOT RECEIVED, LOG REVIEW ONLY. THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT RECEIVING A PCA INFUSION DESATURATED AND CODED. INITIALLY POST-OP THE PATIENT WAS ON DILAUDID PCA FOR 2 HOURS BUT WAS NOT RECEIVING RELIEF. AT APPROXIMATELY 9 PM THE INFUSION WAS CHANGED TO MORPHINE 30 MG/30 ML WITH NO BASAL RATE, PCA DOSE 2 MG, 6 MINUTE LOCKOUT, MAX LIMIT 12 MG/HR. (THE INITIAL ORDER HAD BEEN FOR A MAX LIMIT OF 20 MG/HR BUT THE PHARMACIST CALLED THE PHYSICIAN TO ADJUST IT AS THE PHARMACIST FELT THAT WAS TOO HIGH A LIMIT.) THE PATIENT WAS DOING WELL UNTIL AROUND MIDNIGHT WHEN SHE DETERIORATED AND REQUIRED RESUSCITATION. THE MORPHINE WAS STOPPED AND THE PATIENT WAS INTUBATED AND WAS NOT DOING WELL AFTER THE EVENT. THE CUSTOMER REQUESTS AN EVENT LOG REVIEW FOR A POSSIBLE OVER INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436976 ALARIS PCA MODULE PCA INFUSION DEVICE MEA CAREFUSION CORP. 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention ALARIS ETCO2 MODULE, SN (B)(4)| ALARIS PUMP MODULE, SN (B)(4)| EXTENSION SET, MANUFACTURER/MODEL/LOT UNK| ALARIS PUMP MODULE TUBING, MODEL/LOT UNK| IMS 30 ML SYRINGE, MODEL/LOT UNK| ALARIS PC UNIT, SN (B)(4)