BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE IV ADMINISTRATION SET

    MDR report key: 2121168 · Received May 4, 2011

    Report

    Report Number
    9616066-2011-00177
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    October 8, 2010
    Report Date
    January 11, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: (B)(4) 2011. (B)(4). THE CUSTOMER'S REPORT OF TUBING FOUND CRACKED WAS NOT VERIFIED, HOWEVER, CUTS ON THE OPPOSITE SIDES OF THE PVC TUBING RIGHT BELOW THE ANTISIPHON VALVE WERE OBSERVED. THE CUT TUBING WAS CONFIRMED TO LEAK. THE ROOT CAUSE OF THE CUTS WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED CRACK FOUND IN TUBING (LOCATION UNKNOWN). SET WAS INFUSING FENTANYL. TUBING VOLUME OF APPROXIMATELY 20MLS WAS LOST. NO REPORT OF A LEAK. THE SET WAS CHANGED OUT. NO HARM TO THE PATIENT OR MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PCA MODULE IV ADMINISTRATION SET FPA CAREFUSION CORPORATION 30883 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SODIUM CHORIDE| ALARIS PCA MODULE: S/N UNKNOWN| MONOJECT PREFILL ADVANCED SYRINGE 0.9%, 10ML| ALARIS PC UNIT: S/N UNKNOWN