BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3103468 · Received May 9, 2013

    Report

    Report Number
    1416980-2013-11902
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 27, 2013
    Report Date
    April 27, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. THE REPORTED ISSUE WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING CONNECTION ISSUE WHICH OCCURRED ON THE HOMECHOICE. THE HOME PATIENT (HP) STATED THAT HE MOVED AND ONE OF THE SUPPLY LINES BECAME DISCONNECTED. THE HP STATED HE THEN RECONNECTED THE SUPPLY LINE TO THE SETUP. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE HP WITH ENDING THERAPY AND ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES AND INFORM HIS REGISTERED NURSE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER HEALTHCARE CONTACTED THE HP. HE STATED THAT HE DID NOT NOTICE ANYTHING UNUSUAL ABOUT HIS SUPPLIES THAT NIGHT, AND HE DID NOT KNOW WHAT CAUSED THE DISCONNECT. THERE WERE NO ADVERSE EFFECTS REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202781 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOMECHOICE