BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH

    MDR report key: 2024218 · Received March 18, 2011

    Report

    Report Number
    1423500-2011-03411
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RECEIVED AND INVESTIGATED. THE CAUSE FOR THE REPORTED EVENT WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED. A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510K NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    REPORTEDLY ON (B)(6) 2011, THE HOME PATIENT (HP) USING THE UV FLASH STATED THAT THE DISCONNECT CAP WILL NOT DISCARD AUTOMATICALLY WHEN THE DOOR WAS OPEN. THEREFORE, THE HP HAD TO MANUALLY CONNECT HERSELF. TECHNICAL SERVICE REPRESENTATIVE (TSR) AGREED TO SWAP THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV-FLASH SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1