BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE

    MDR report key: 2901682 · Received January 2, 2013

    Report

    Report Number
    2016493-2012-00532
    Event Type
    Injury
    Date Received
    January 2, 2013
    Report Date
    December 5, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    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). A CAREFUSION CLINICAL PRACTICE CONSULTANT PHARMACIST REVIEWED THE PROGRAMMING AND PATIENT HISTORY. ACCORDING TO THE PATIENT HISTORY FROM 14:33-17:56, THE TOTAL DRUG DELIVERED WAS 4.42MG. ADDING A PCA DOSE OF 0.6MG AND A CONTINUOUS DOSE OF 0.1MG/HR WOULD EQUATE TO 5.12MG, WHICH WOULD PUT THE PATIENT ABOVE THE TOTAL MAX ACCUMULATED DOSE LIMIT OF 5MG/4HOURS. NO ISSUES WITH PROGRAMMING OR FUNCTIONALITY WERE IDENTIFIED AND NO DEVICES ARE EXPECTED TO BE RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT REQUIRED ADDITIONAL MEDICATION BECAUSE NOT ALL EXPECTED PCA DOSES WERE ADMINISTERED. THE MEDICATION CONCENTRATION WAS 12MG/30ML OR 0.4MG/ML. PCA DOSE OF 0.6MG, LOCKOUT INTERVAL 10 MINUTES, CONTINUOUS DOSE 0.1MG/HR AND MAX LIMIT OF 5MG/4HR. EIGHT PCA DEMANDS WERE DOCUMENTED BUT ONLY SEVEN DOSES WERE ADMINISTERED. A FEW INSTANCES DURING THE TIME, THIS PATIENT WAS CONNECTED TO THE PCA THERE WAS ONE PCA DOSE THAT WAS NOT DELIVERED. THE CUSTOMER CHANGED THE PCU AND PCA TWICE YET THE PROBLEM CONTINUED. THE NURSE CALLED THE DOCTOR AND TORADOL (NOT SURE IF PO OR IV) WAS ORDERED FOR PAIN. THE PATIENT HAD THE PCA DISCONTINUED BUT WAS STILL IN THE HOSPITAL AT THE TIME OF THE REPORT. THE PHARMACIST THOUGH THERE MIGHT BE SOMETHING WRONG WITH THE WAY THE DATA SET IS CONFIGURED. THE CUSTOMER SENT A SCREEN SHOT OF THE PROGRAMMING FROM THE PUMP DISPLAY AND PATIENT HISTORY. NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PCA ADMINISTRATION SET, MODEL/LOT UNK| ALARIS PC UNIT, SN UNK