BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1920224 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06750
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING INITIAL DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE HOME PATIENT (HP) STATED HE DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE THAT WAS IN USE. THE HP STATED THERE WERE NO DISCONNECTIONS, SEPARATIONS OR HOLES IN ANY LINES. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE HOME PATIENT (HP) REPORTED A SYSTEM ERROR (SE) 2240. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CYCLE POWER AND THE HC ALARMED WITH THE SE 2367. THE TSR HAD THE HP CYCLE POWER AGAIN TO GET BACK TO PRESS GO TO START. THE TSR EXPLAINED THE ALARMS TO THE HP AND ADVISED WOULD NEED TO START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) REGARDING THE REPORTED EVENT. THE HP STATED HE DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE THAT WAS IN USE. THE HP STATED THERE WERE NO DISCONNECTIONS, SEPARATIONS OR HOLES IN ANY LINES. THE HP STATED HE DISCARDED THE SAMPLE AND DID NOT KNOW THE LOT NUMBER. THE HP STATED THE BAXTER TECHNICIAN EXPLAINED THE CAUSE OF THE ALARM MAY HAVE BEEN THAT A LINE WAS CAUGHT UNDER THE WHEEL OF THE HP'S BED AND CAUSED AIR TO GO BACK INTO THE CYCLER. THE HP WAS ADVISED TO INFORM HIS PERITONEAL DIALYSIS NURSE OF THE ALARM. THE HP STATED HE WAS ABLE RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1