BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH COMPACT

    MDR report key: 1513574 · Received October 22, 2009

    Report

    Report Number
    1423500-2009-00478
    Event Type
    Malfunction
    Date Received
    October 22, 2009
    Date of Event
    August 24, 2009
    Report Date
    September 30, 2009
    Manufacturer
    MED-TECH INC.
    Product Code
    KDJ
    PMA / PMN Number
    K883239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD THE SAMPLE BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THAT A FEMALE PATIENT, WHO IS SUFFERING OF ALZHEIMERS DISEASE AND IS DIALYZED AT HOME THROUGH A BAXTER UV FLASH SYSTEM HAD TORN AWAY THE BAXTER UV FLASH SOLUTION TRANSFER SET. ACCORDING TO THE REPORTER, THE HOME PATIENT (HP) HAD TORN AWAY THE TRANSFER SET AT THE LEVEL OF THE WHITE CONNECTION. IT WAS STATED THAT THE HP IS SUFFERING OF ALZHEIMERS AND THAT SHE COULD HAVE PULLED UP ON THE LINE AND CAUSED THE DISCONNECTION. THERE IS NO CLINICAL CONSEQUENCES REPORTED FOR THE PATIENT. THE SAMPLE IS AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-FLASH COMPACT SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ MED-TECH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1