BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 2140560 · Received June 15, 2011

    Report

    Report Number
    9616066-2011-00315
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Report Date
    March 21, 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 COMPLAINT OF LEAK IN THE SILICONE SEGMENT WAS CONFIRMED. A TEAR WAS OBSERVED IN THE SILICONE TUBING AT THE UPPER FITMENT; HOWEVER, THE SILICONE SEGMENT WAS NOT TORN IN TWO, AS INITIALLY REPORTED BY THE CLINICIAN. THE ROOT CAUSE OF THE TEAR IN THE SILICONE TUBING WAS UNDETERMINED. ALTHOUGH, LOT NUMBER UNKNOWN, THE SMARTSITE LASER NUMBER INDICATES THIS SET WAS BUILT BETWEEN 01/12/2011 AND 02/03/2011. THE EXPIRATION DATE WOULD BE EITHER 01/01/2014 AND 02/01/2014.

    Description of Event or Problem · 1

    CUSTOMER REPORTED, THE SET PULLED APART (TORN IN TWO) AT THE SILICONE SEGMENT DURING AN INFUSION VIA A PUMP MODULE. NO PATIENT HARM OCCURRED. CUSTOMER STATES NO FURTHER PATIENT EVENT INFORMATION IS AVAILABLE.

    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