BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE

    MDR report key: 3454891 · Received September 18, 2013

    Report

    Report Number
    2016493-2013-00405
    Event Type
    Malfunction
    Date Received
    September 18, 2013
    Date of Event
    June 11, 2013
    Report Date
    June 12, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MFR. THE REQUESTED LOG REVIEW HAS BEEN COMPLETED AND THE REPORTED CHANNEL ERROR 511.2010 WAS CONFIRMED VIA LOG ANALYSIS. THE REPORTED DISPLAYED ERROR CODE 13-1033-149 ON THE PCU SCREEN COULD NOT BE CONFIRMED AND THE PCU ERROR LOG HAD NO ASSOCIATED ERROR EVENT LOGGED. THE LOG ANALYSIS INDICATED THERE WERE TWO EVENTS OF CHANNEL ERROR 511.2010 OCCURRING, WITH THE PCA AND ETCO2 HAVING BEEN REMOVED AND ADDED BACK TO THE SYSTEM JUST PRIOR TO THE ERROR EVENTS. THE SECOND ERROR EVENT HAD A CHANNEL DISCONNECT ALARM EVENT JUST PRIOR TO THE CHANNEL ERROR AND WHEN THE DEVICES WERE ADDED BACK TO THE SYSTEM THE CHANNEL ERROR EVENT OCCURRED. BOTH REPORTED ERROR EVENTS MOST LIKELY ARE THE RESULT OF A COMMUNICATION INTERRUPT OCCURRING INTERMITTENTLY. THE LOGGED EVENTS OF THE DEVICES BEING REMOVED AND ADDED TO THE SYSTEM PRIOR TO THE ERROR EVENTS SUGGEST THERE MAY HAVE BEEN CONDUCTIVITY PROBLEMS OCCURRING AT AN IUI CONNECTION INTERFACING BUT THIS ISSUE COULD NOT BE INVESTIGATED ANY FURTHER DUE TO THE FACT NO DEVICES WERE RETURNED FOR AN INVESTIGATION. THE ROOT CAUSE FOR THE CUSTOMER'S REPORTED EXPERIENCE COULD NOT BE IDENTIFIED FROM A LOG ANALYSIS AND NO MORE INFORMATION WAS MADE AVAILABLE.

    Description of Event or Problem · 1

    DURING TRAINING, A NURSE WAS PRIMING THE TUBING THROUGH THE PCA MODULE WHEN THE CHANNEL ERROR APPEARED ON THE ETCO2 MODULE SCROLLING 511-2010. THERE WAS A CHANNEL ERROR MESSAGE ON THE PCU DISPLAYING 13-1033-149. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471272 ALARIS PCA MODULE FRN CAREFUSION CORP 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| ALARIS ETCO2: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| PCA ADMINISTRATION SET: MFR, MODEL AND LOT UNK