BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXPLUS CLEAR NEEDLELESS CONNECTOR

    MDR report key: 3108448 · Received May 3, 2013

    Report

    Report Number
    9616066-2013-00313
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE AFFECTED PRODUCT WAS DISCARDED. UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED PROBLEM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING RESUSCITATION EFFORTS IN ICU THEY TRIED TO ACCESS THE MP 1000C VALVE THAT IS ATTACHED TO A PICC PORT AND THEY EXPERIENCED PROBLEMS CONNECTING THE MALE LUER, FROM EITHER THE PUMP TUBING OR A SYRINGE, BECAUSE IT REPEATEDLY SLIDES OFF THE SURFACE OF THE VALVE. OR, WHEN THEY WERE ABLE TO CONNECT A SYRINGE OR PUMP TUBING MALE LUER THEY EXPERIENCED DIFFICULTY GIVING IV PUSH MEDICATIONS AND/OR GIVING FLUIDS AT A HIGH RATE VIA THE PUMP. IT IS UNCLEAR IF MEDICAL INTERVENTION WAS REQUIRED AS A DIRECT RESULT OF THE PRODUCT PROBLEM; THE PATIENT WAS BEING RESUSCITATED AT THE TIME OF THE EVENT. AFTER BEING RESUSCITATED THE PATIENT WAS MADE DNR AND DIED 24 HOURS LATER. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195405 MAXPLUS CLEAR NEEDLELESS CONNECTOR FPA CAREFUSION CORPORATION MP1000-C 12018066

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death ALARIS PC UNIT, SN UNKNOWN| LOT NUMBER UNKNOWN| ALARIS PUMP MODULE ADMIN SET, MODEL 2426-0500| ALARIS PUMP MODULE, SN UNKNOWN| PICC LINE, MANUFACTURER, MODEL/LOT UNKNOWN