BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2040293 · Received April 5, 2011

    Report

    Report Number
    1423500-2011-04133
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 28, 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 LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING DWELL (B)(4) WAS NOT CONFIRMED. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING DWELL. THE HP STATED HIS SUPPLY BAG IS EMPTY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED IN CLEARING THE ALARM THEN EXPLAINED A SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND THEN ENDED THERAPY AND START OVER WITH NEW SUPPLIES. THE HP WAS ALSO TOLD TO INFORM THEIR NURSE. THE PATIENT WAS INVOLVED, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. A FOLLOW UP WAS MADE VIA PHONE CALL. THE HP STATED HE WAS NOT SURE WHAT CAUSED THE ALARM. THE HP CONFIRMED HE STARTED OVER WITH NEW SUPPLIES. THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN. THE HP HAS CONTINUED THERAPY NO INJURY OR MEDICAL INTERVENTION REPORTED AS A RESULT OF THIS INCIDENT.

    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 HOMECHOICE