BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2170226 · Received July 20, 2011

    Report

    Report Number
    1423500-2011-09242
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 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 COMPLAINT FOR A CONNECTION ISSUE WAS CONFIRMED BECAUSE THE NURSE STATED THAT SUPPLY LINE BAG FELL AND BECAME DISCONNECTED. THE CAUSE WAS IDENTIFIED AS SUPPLY BAG FELL AND BECAME DISCONNECTED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    A CAREGIVER (CG) CONTACTED (B)(4) REGARDING A SUPPLY BAG THAT FELL AND DISCONNECTED DURING DWELL 1 OF 4 OF THERAPY ON THE HOMECHOICE (HC) UNIT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR ALSO ADVISED THE CG TO INFORM THE NURSE OF THE INCIDENT IN THE NEXT 24 HOURS. THE TSR FURTHER ASSISTED THE CG TO END THERAPY. THE CG CONFIRMED TO START OVER WITH NEW SUPPLIES. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) REGARDING THE DISCONNECTION. THE HP STATED THE BAG FELL BECAUSE THE STAND USED TO PLACE THE BAG ON WAS LOOSE. THE HP CONFIRMED THERE WERE NO DEFECTS WITH THE SUPPLIES. THE HP STATED THE REGISTERED NURSE (RN) WAS INFORMED REGARDING THE DISCONNECTION AND EVERYTHING HAD BEEN FINE SINCE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    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 25 YR HOMECHOICE