BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2771074 · Received October 3, 2012

    Report

    Report Number
    1416980-2012-01500
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 14, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. THIS COMPLAINT FOR AIR IN TUBING (WITHOUT ALARM) WAS CONFIRMED BECAUSE THE PATIENT REPORTED THAT THEY HAD LEFT ONE OF THE UNUSED LINES OPEN. THE ASSIGNABLE CAUSE IS USE ERROR. A LABELING REVIEW HAS BEEN PERFORMED, FINDING THAT CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERROR.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A CHECK LINES AND BAGS ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE IN THE PREVIOUS CYCLE, DURING DWELL 4 OF 4. THE DWELL TIME EQUALED :54. THE HOME PATIENT (HP) REALIZED THERE WAS AN UNUSED LINE THAT WAS OPEN. THEY CLOSED IT AND THE HC WENT TO DWELL. THE HEATER BAG WAS EMPTY AND THE LAST FILL HAD SOLUTION. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED ABOUT LEAVING UNUSED LINES OPEN. THE HP SAW AIR IN THE DRAIN LINE. THE TSR EXPLAINED AND ADVISED TO END THERAPY. THE HP SAID THAT THEY KNEW HOW TO END THERAPY AND WOULD END IT ON THEIR OWN. THE TSR SUGGESTED TO LET THE REGISTERED NURSE (RN) KNOW ABOUT GETTING AIR IN LINES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT ON (B)(6) 2012 IN REGARDS TO AIR IN TUBING (WITHOUT ALARM) AND HE SAID, HE JUST DISCONTINUED THERAPY THAT NIGHT. HE SAID, HIS WIFE HAD LEFT THE CLAMP OPEN ON AN UNUSED LINE AND THAT WAS HOW AIR GOT IN. SINCE THEN HE HAS BEEN COMPLETING THERAPY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR HOMECHOICE