BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3070810 · Received April 22, 2013

    Report

    Report Number
    1416980-2013-09989
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE PATIENT AT-HOME GUIDE, USERS ARE INSTRUCTED NOT TO REUSE PRODUCTS INTENDED FOR SINGLE USE. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REUSE OF A SINGLE USE PRODUCT DURING PERITONEAL DIALYSIS THERAPY ON THE HOMECHOICE (HC). THE HOME PATIENT (HP) WAS IN PRIMING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE ALARM LOG. THE HP HAD A NUMBER OF ALARMS AND HAD TRIED TO OPEN THE DOOR. THE HP STARTED OVER USING THE SAME SUPPLIES AND THEY WERE IN PRIME. THE HP THEN GOT A CHECK SUPPLY LINE ALARM DUE TO NOT HAVING ENOUGH SOLUTION CONNECTED TO INITIATE A THERAPY. THE TSR REVIEWED THE ALARMS WITH HP. THE HP WAS IN DWELL 3 AND WOULD COMPLETE THERAPY WITH MANUAL SUPPLIES REVIEWED ALARM. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172371 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR HOMECHOICE