BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2243309 · Received September 12, 2011

    Report

    Report Number
    1423500-2011-12054
    Event Type
    Malfunction
    Date Received
    September 12, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 21, 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 DEVICE HAD BEEN DISCARDED AND THE LOT NUMBER WAS UNKNOWN, A BATCH REVIEW COULD NOT BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PROBLEM WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS RELATED TO USE ERROR. A LABELING REVIEW FOUND THE LABELING TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A LOW DRAIN VOLUME ALARM (LVD) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE CAREGIVER (CG) STATED THAT HC WAS ALARMING OVER AND OVER AND THERE WAS AIR IN THE PATIENT LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE CG TO START OVER WITH NEW SUPPLIES AND EXPLAINED AIR EXPOSURE. THE CG WAS UPSET ABOUT HAVING TO START OVER WITH NEW SUPPLIES AND HUNG UP ON TSR BEFORE TSR COULD DOCUMENT DRAIN VOLUME OR LAST FILL VOLUME. THE CG WOULD START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION BUT THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED THE CG ON (B)(6) 2011 REGARDING THE REPORT OF AIR IN THE LINE. THE CG STATED THAT THE HOME PATIENT (HP) DID NOT PRIME THE PATIENT LINE COMPLETELY BEFORE CONNECTING. SHE THEN SAW THE AIR IN THE LINE AFTER SHE CONNECTED. SHE STOPPED INITIAL DRAIN AND DISCONNECTED. PER THE CG, THERE WERE NO LOOSE CONNECTIONS, (UNINTENTIONAL) DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER CG, THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE CG STATED THAT THE HP WAS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE CG STATED THAT HE HAD DISCARDED THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBERS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    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 57 YR HOMECHOICE