BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTI-SIPHON PCA EXTENSION SET

    MDR report key: 1823142 · Received September 1, 2010

    Report

    Report Number
    6000001-2010-02933
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K840760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LABELING REVIEW FOUND THE LABEL CONTAINS THE APPROPRIATE CAUTIONS, WARNINGS AND DIRECTIONS FOR USE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THE LOT NUMBER IS NOT KNOWN, THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS CRACKING ON THE HOUSING OF THE Y-SITE WHICH IS CAUSING A BACKUP OF BLOOD INTO THE Y-SYSTEM. THE CUSTOMER IS ATTEMPTING TO ACCESS THE Y-SITE WITH A CLAVE DEVICE. THE REPORTED CONDITION OCCURRED DURING PATIENT USE. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTI-SIPHON PCA EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1