BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 4122812 · Received September 26, 2014

    Report

    Report Number
    1416980-2014-33445
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 3, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBER H14G23035 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. THE CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYSTEM ERROR (SE) 2240 (AIR IN SET/LINE) ALARM OCCURRED DURING USE ON THE HOMECHOICE (HC). THE REGISTERED NURSE (RN) STATED THAT THE HOME PATIENT (HP) HAD DISCONNECTED FROM THE SET UP AFTER THE ALARM OCCURRED. THE HP COULD NOT IDENTIFY ANYTHING THAT WOULD HAVE TRIGGERED THE ALARM. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601405 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H14G23035

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOMECHOICE