BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTICAP

    MDR report key: 3180562 · Received June 20, 2013

    Report

    Report Number
    1416980-2013-16016
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS NOT AVAILABLE; THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OPTICAP HAD A CONNECTION ISSUE WITH A PATIENT LINE DURING HOME PATIENT (HP) USE WHILE THE HP WAS NOT CONNECTED. THE HP HAD DISCONNECTED FROM THE HOMECHOICE (HC) AND PUT THE OPTICAP ON THE PATIENT LINE. HOWEVER, WHEN THE HP TRIED TO RECONNECT TO THE HC, THE HP COULD NOT TAKE OPTICAP OFF FROM THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO END THE THERAPY AND START OVER USING ALL NEW SUPPLIES OR CONTINUE THE THERAPY USING MANUAL SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280331 OPTICAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE| HOMECHOICE