BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2071330 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05113
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 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). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT ON (B)(6) 2011. ACCORDING TO THE PATIENT SHE DOES NOT THINK THERE WERE ANY DEFECTS IN THE SUPPLIES, HOWEVER, SHE DOES NOT HAVE ANY INFORMATION REGARDING THIS EVENT. THE PATIENT BELIEVES THEY DISCARDED THE SUPPLIES AND STARTED OVER WITH NEW ONES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE PATIENT HAS RESUMED THERAPY. NO FURTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORT OF AIR WAS NOT CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. THE LABELING REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USER ERROR. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER AND REQUESTED TO END THERAPY DURING THE INITIAL DRAIN. THE CAREGIVER (CG) STATED THAT THE HOME PATIENT (HP) HAS AIR IN HER LINE AND THE CG NEEDS TO END THE THERAPY TO START OVER. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CYCLE POWER OFF/ON AND END THE THERAPY. THE CG STATED HE WILL NOW START OVER WITH ALL NEW SUPPLIES.

    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 PD CYCLER