BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SECONDARY ADMINISTRATION SET

    MDR report key: 4250223 · Received November 6, 2014

    Report

    Report Number
    9616066-2014-01097
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    July 17, 2014
    Report Date
    August 6, 2014
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K790582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REFERENCE ASSOCIATED MDR # 2016493-2014-00418 FOR THE PUMP MODULE COMPLAINT. CONCLUSION FIELD LEFT BLANK - NO AVAILABLE CODE FOR UNDETERMINED OR UNKNOWN CAUSE. THE SECONDARY SET WAS INSPECTED FOR INCOMPLETE BONDING ENGAGEMENTS AND HOLES/TEARS IN THE TUBING. A HOLE WAS OBSERVED APPROXIMATELY 13 INCHES FROM THE MALE LUER. THE SET WAS THEN PRESSURE TESTED WHILE SUBMERGED UNDERWATER. LEAKING WAS OBSERVED AT A PRESSURE LESS THAN 5PSI. THE ROOT CAUSE OF THE CUT WAS NOT IDENTIFIED. THERE WAS NO MENTION OF LEAKING BY THE CUSTOMER AND THEREFORE IT CANNOT BE DETERMINED IF THE CUT WAS PRESENT AT THE TIME OF THE INFUSION OR IF THE CUT OCCURRED DURING TRANSPORTATION OF THE SET BACK TO CAREFUSION FOR EVALUATION.

    Description of Event or Problem · 1

    DURING FAILURE INVESTIGATION OF THE RETURNED DISPOSABLE SETS, A CUT WAS NOTED IN THE TUBING OF THE SECONDARY SET AND LEAKING WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714385 ALARIS SECONDARY ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORP. 11582774

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR LOT NC086710, EXP 05/15/2015| ALARIS PUMP MODULE: SN (B)(4)| BAXTER IV BAG OF 1000ML LACTATED RINGER'S| ALARIS PCU: SN (B)(4)| INJECTION USP: LOT C920603, EXP 04/2015| BAXTER IV BAG OF 500ML VANCOMYACIN INJECTION USP:| ALARIS PRIMARY TUBING: MODEL 2426-0500, LOT UNK