BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE ADMINISTRATION SET

    MDR report key: 2082573 · Received April 27, 2011

    Report

    Report Number
    9616066-2011-00161
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    April 4, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 04/27/2011. (B)(4). THE SET HAS BEEN REC'D BUT THE INVESTIGATION IS NOT COMPLETE. A F/U REPORT WILL BE SUBMITTED ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LEAKING SET AND WAS UNSURE WHEN THE LEAK OCCURRED. CUSTOMER STATED THAT THE LEAK WAS POSSIBLY FROM THE FEMALE LUER AREA BUT NOT SURE; THE USER MARKED THE LEAKING AREA WITH TAPE. A NOTE, THE RPTR REC'D WITH THE SET STATED IT WAS NOT CAUSED BY A CONNECTION ISSUE AS THE LEAK APPEARED TO BE FROM THE SET ITSELF AND NOT THE CONNECTION. SHE DOES NOT HAVE ANY CLINICAL CONTACT INFO AND DID NOT RECEIVE ANY REPORT OF PT HARM OR MEDICAL INTERVENTION. CUSTOMER STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PCA MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION 30893 10116453

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PC UNIT, S/N UNKNOWN| ALARIS PCA, S/N UNKNOWN