BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3181130 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16076
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) EXPERIENCED A CONNECTION ISSUE. THIS OCCURRED AT AN UNSPECIFIED TIME DURING PD THERAPY. THE HP HAD DISCONNECTED AND PUT A MINICAP ON HER TRANSFER SET AND AN OPTICAP ON THE PATIENT (PT) LINE OF THE CASSETTE. WHEN THE HP WAS ATTEMPTING TO RECONNECT TO CONTINUE THERAPY, THE HP COULD NOT GET THE OPTICAP OFF OF THE PT LINE. UPON CONTACTING A BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR), THE HP WAS ADVISED THAT THERAPY WOULD HAVE TO BE ENDED, IF THEY COULD NOT GET THE OPTICAP OFF AND THAT THE HP WOULD HAVE TO START OVER WILL ALL NEW SUPPLIES OR CONTINUE WITH MANUAL SUPPLIES. THE HP INDICATED THAT THEY WOULD TRY TO REMOVE THE CAP AND WILL CALL BACK IF THEY COULD NOT GET IT OFF. THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO ADVERSE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283227 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 OPTICAP| HOMECHOICE