BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1761020 · Received July 19, 2010

    Report

    Report Number
    1423500-2010-01540
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    July 4, 2010
    Report Date
    July 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO SAMPLE WAS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) TO REPORT AN ALARM WITH THE HOMECHOICE (HC) MACHINE DURING DRAIN 1 OF 6. THE REGISTERED NURSE (RN) STATED SHE PRIMED THE PATIENT LINE COMPLETELY, BUT WHEN THE ALARM STARTED GOING OFF, THE PATIENT LINE WAS COMPLETELY FILLED WITH AIR. THE RN STATED THAT RIGHT BEFORE THE ALARM WENT OFF, THE HOME PATIENT (HP) WENT TO THE RESTROOM, BUT THE HP STATED SHE DID NOT DISCONNECT HERSELF WHEN SHE DID. THE RN WAS NOT SURE IF SHE HAD. (B)(4) EXPLAINED THE RN WOULD NEED TO START THERAPY OVER WITH NEW SUPPLIES AND ADVISED THE RN TO CALL THE PERITONEAL DIALYSIS (PD) RN WITHIN 24 HOURS. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE CALLER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE SPOKE WITH THE HP ON (B)(6) 2010. THE HP STATED THAT SHE HAD DISCONNECTED INTENTIONALLY TO GO TO THE BATHROOM AND CAME BACK AND RECONNECTED. THE HP COULD NOT REMEMBER IF SHE HAD PUT A CAP ON THE LINE AND STATED SHE HAD NOT CHECKED THE LINE FOR AIR BEFORE RE-CONNECTING. THE HP HAS BEEN DOING FINE EXCEPT CHRONIC ISSUES UNRELATED TO PD AND HAS BEEN CONTINUING THERAPY ON THE CYCLER AS USUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR