BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2022340 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03286
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 24, 2011
    Report Date
    February 24, 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). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS AIR IN LINE DUE TO THE PATIENT NOT PROPERLY PRIMING THE DISPOSABLE SET. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR A USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A LOW DRAIN VOLUME ALARM THAT OCCURRED ON THE HOME CHOICE (HC) MACHINE DURING INITIAL DRAIN. THE DRAIN VOLUME (DV) = -6 ML AND THE LAST FILL VOLUME = 2000 ML. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP WITH TROUBLESHOOTING. THE HP STATED THE PATIENT LINE HAD A LOT OF AIR AND FURTHER STATED THE PATIENT LINE HAD AIR WHEN HE CONNECTED. THE TSR EXPLAINED TO THE HP IF THE PATIENT LINE HAD AIR HE SHOULD NOT CONNECT HIMSELF; INSTEAD, SHOULD REPRIME THE PATIENT LINE. THE TSR ADVISED TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE HP CONFIRMED TO START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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 59 YR HOMECHOICE PRO