BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2140528 · Received June 15, 2011

    Report

    Report Number
    9616066-2011-00330
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    March 26, 2011
    Report Date
    March 28, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS EVALUATED AND CUSTOMER'S REPORT OF A LEAK IS CONFIRMED. VISUAL EXAMINATION SHOWS A TEAR IN THE SILICONE TUBING AT THE UPPER FITMENT. ROOT CAUSE OF THE TEAR IN THE SILICONE TUBING IS UNDETERMINED. ALTHOUGH LOT NUMBER UNKNOWN, THE SMARTSITE LASER NUMBER INDICATES THIS SET WAS BUILT BETWEEN 11/23/2010 AND 12/07/2010. THE EXPIRATION DATE WOULD BE EITHER 11/01/2013 OR 12/01/2013.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A TEAR IN THE SOFT TUBING CLOSE TO THE JUNCTION. THE PATIENT PUSHED HER IV PUMP TO THE NURSING STATION AND SAID HER IV WAS LEAKING. CUSTOMER STATES THERE IS NO FURTHER PATIENT OR EVENT INFORMATION AVAILABLE. NO PATIENT HARM WAS REPORTED OR INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 2426-0500 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PUMP MODULE: S/N UNKNOWN| ALARIS PC UNIT: S/N UNKNOWN