BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3063787 · Received April 3, 2013

    Report

    Report Number
    9616066-2013-00221
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 19, 2013
    Manufacturer
    CARFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED KINKED TUBING BECAUSE THE SET WAS DISCARDED BY THE CUSTOMER. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE TUBING WAS FOUND KINKED RIGHT ABOVE THE UPPER BLUE FITMENT DURING AN INFUSION. THE PUMP DID ALARM. DUE TO A LACK OF FLOW, THE PT ENDED UP HAVING AN OCCLUDED PICC LINE AND REQUIRED CATH-FLO TO DECLOT IT. CUSTOMER REPORTS THAT THEIR BAGS WERE HUNG HIGH ENOUGH. IT WAS ALSO REPORTED THAT THE TUBING IS SOFTER AT THE KINK SITE AFTER FLUID HAS BEEN INFUSING AS OPPOSED TO WHEN OPENING THE PACKAGE TO BEGIN THE INFUSION. THE CUSTOMER PROVIDED A PICTURE OF THE ISSUE. NO PRODUCT WAS SAVED. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135423 ALARIS PUMP MODULE ADMINISTRATION SET FPA CARFUSION CORP. 2420-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PUMP MODULE: SN UNK| ALARIS PC UNIT, SN UNK