BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2081784 · Received May 9, 2011

    Report

    Report Number
    1423500-2011-05619
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW WAS NOT REQUESTED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF AN INCOMPLETE PRIME WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) AND REPORTED THAT THE PATIENT LINE DOES NOT HAVE ANY SOLUTION IN IT, SO HE NEEDS TO START OVER. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) WITH THE INCOMPLETE PRIME. THE HP STATED HE DISCONNECTED. THE TSR HAD THE HP CYCLE THE POWER. THE TSR ASSISTED THE HP WITH ENDING THE THERAPY AND GETTING THE SET OUT. THE TSR EXPLAINED THE HP CAN START OVER WITH ALL NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2011 AND NOTIFIED THE NURSE OF THE INCOMPLETE PRIME. ACCORDING TO THE NURSE THE PATIENT DID NOT REPORT ANY ISSUES OR SYMPTOMS. THE PATIENT HAS BEEN TO THE CLINIC SINCE THIS EVENT AND HAS RESUMED THERAPY WITH NO PATIENT INJURY OR MEDICAL INTERVENTION. NO FURTHER INFORMATION IS AVAILABLE.

    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 56 YR HOMECHOICE