BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXPLUS CLEAR NEEDLELESS CONNECTOR

    MDR report key: 3108466 · Received May 3, 2013

    Report

    Report Number
    9616066-2013-00314
    Event Type
    Death
    Date Received
    May 3, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 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. THIS PATIENT WAS REPORTED TO HAVE "CODED" 3 TIMES, AND DID NOT SURVIVE THE THIRD CODE. THERE IS NO DIRECT CUSTOMER ALLEGATION THAT A DEVICE MALFUNCTION DIRECTLY CAUSED OR CONTRIBUTED TO THE PATIENT DEATH. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193492 MAXPLUS CLEAR NEEDLELESS CONNECTOR FPA CAREFUSION CORPORATION MP1000-C 12018066

    Patients

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