BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE ADMINISTRATION SET

    MDR report key: 2885095 · Received December 12, 2012

    Report

    Report Number
    9616066-2012-00891
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 16, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K811885
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE REPORTED LEAK. THE CUSTOMER REPORTED THAT THE SET WAS NOT SAVED AND IS NOT AVAILABLE FOR EVAL.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE PCA HAD BEEN INFUSING FOR SEVERAL HOURS WHEN FLUID WAS NOTED RUNNING DOWN THE OUTSIDE OF THE TUBING. UPON INSPECTION, THE LUER OF THE SYRINGE WAS NOTED TO BE CRACKED. THE CUSTOMER STATED THEY BELIEVE THE PCA TUBING CAUSED THE SYRINGE TO CRACK. THE PT COMPLAINED OF INADEQUATE PAIN RELIEF DUE TO THE LEAK; A DOSE OF TORADOL WAS ORDERED AND WAS GIVEN WITH GOOD RESULTS. NEITHER THE SET NOR THE SYRINGE WERE SAVED. THE REPORTER 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 30853 12105393

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PCA MODULE: SN UNK| ALARIS PC UNIT: SN UNK| PCA SYRINGE: MODEL/LOT/MFR UNK