BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4080862 · Received August 26, 2014

    Report

    Report Number
    9616066-2014-00847
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Report Date
    July 31, 2014
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MFR. NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS DISCARDED AND NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE IV TUBING DISCONNECTED FROM THE PHASEAL DURING AN INFUSION OF CHEMOTHERAPY, RESULTING IN LEAKAGE. NO PT HARM OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER PT/EVENT INFO WAS PROVIDED. MFR'S REPORT NUMBER: 9616066-2014-00847. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515533 ALARIS PUMP MODULE ADMINISTRATION SET IV SET FPA CAREFUSION CORP. 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MODEL/LOT UNK, THERAPY DATE UNK| GROSHONG OR MEDIPORTS CENTRAL LINE| ALARIS PC UNIT & PUMP MODULE, SNS UNK| THERAPY DATE UNK| LOT UNK, THERAPY DATE UNK| MAXZERO NEEDLELESS CONNECTOR, MODEL MZ1000-07| PHASEAL, MODEL 515202, LOT UNK