BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 3060638 · Received March 27, 2013

    Report

    Report Number
    9616066-2013-00211
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    March 13, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED LEAK BECAUSE THE SET HAD BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED DISCONNECTING OF THE LUER CONNECTION OF STOPCOCKS (NOT SURE IF TECHNICIAN ARE CHECKING/TIGHTENING PRIOR TO USE). CUSTOMER REPORTED A PT EVENT IN WHICH THE SURGEON FOUND A PT HAD LOST 200ML OF BLOOD DUE TO THE DISCONNECTION HAVING LEAKED. THERE WAS NO HARM TO THE PT, AND NO MEDICAL INTERVENTION REPORTED. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127127 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK