BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PCA MODULE

    MDR report key: 2999502 · Received March 6, 2013

    Report

    Report Number
    2016493-2013-00136
    Event Type
    Death
    Date Received
    March 6, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 11, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE NOT RECEIVED, LOG REVIEW ONLY. THE DATA SET AND PCA EVENT LOGS HAVE BEEN RECEIVED. RECEIPT OF PC UNIT EVENT LOGS IS STILL PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH RESULTS OF THE INVESTIGATION ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A BIOMED REPORTED THAT A NURSE USED THE INCORRECT TUBING ON A PCA MODULE AND HE WANTED TO KNOW IF IT COULD HAVE FREE FLOWED TO THE PT SINCE THE TUBING USED DID NOT HAVE AN ANTI-SIPHON VALVE. THE PT WAS RECEIVING PCA MEDICATION WHILE ON A COMFORT CARE REGIMEN, AS THEY WERE EXPECTED TO EXPIRE SOON DUE TO A TERMINAL ILLNESS. THE NURSE REPORTED THAT SHE DID NOT SUSPECT ANY MALFUNCTION OF THE DEVICE HOWEVER SHE HAD BEEN SUSPICIOUS THAT A POSSIBLE FREE FLOW SITUATION COULD HAVE OCCURRED SINCE THEY FOUND FLUIDS ON THE FLOOR AROUND THE END OF THE DISCONNECTED PCA TUBING AFTER THE PT HAD EXPIRED. THE NURSE HAD DISCONNECTED THE TUBING, TURNED OFF THE DEVICE, AND LEFT THE TUBING HANGING OFF OF THE DEVICE. THE BIOMED HAS REQUESTED AN EVENT LOG REVIEW TO SEE WHAT WAS PROGRAMMED AND DELIVERED AND IF THE SYRINGE HAD BEEN REMOVED FROM THE DEVICE WHILE IN USE. THE BIOMED STATED THAT NO FURTHER PATIENT/EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95157 ALARIS PCA MODULE FRN CAREFUSION CORPORATION 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death PCA ADMINISTRATION SET, MANUFACTURER, MODEL| AND LOT # UNK| ALARIS PC UNIT: SN UNK