BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1951807 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00231
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 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 DWELL 4 OF 5 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 THAT SHE DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE THAT WAS IN USE. THE HP STATED THERE WERE NO DISCONNECTIONS OR LOOSE CONNECTIONS THAT MAY HAVE OCCURRED. 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. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES TO REPORT A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DWELL 4 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP AND ADVISED THE HP TO CYCLE POWER TO CLEAR ALARM. THE TSR THEN ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE HP STATED THAT SHE JUST WANTED TO END THERAPY FOR THE NIGHT. THE TSR ADVISED THE HP TO CALL HER NURSE (RN) TO INFORM OF THE INCIDENT AND ANY MISSED THERAPY. ON (B)(6) 2010, PRODUCT SURVEILLANCE CONTACTED THE HP WHO STATED SHE DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE THAT WAS IN USE. THE HP STATED THERE WERE NO DISCONNECTIONS OR LOOSE CONNECTIONS THAT MAY HAVE OCCURRED. THE HP STATED SHE WAS ABLE TO RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. THE HP STATED SHE DID NOTIFY HER NURSE OF THE ALARM AND CONFIRMED HER NURSE REVIEWED PROPER PROCEDURES WITH HER. THE HP STATED SHE WAS NO LONGER ON PERITONEAL DIALYSIS THERAPY AND HAD SWITCHED TO HEMODIALYSIS. 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 53 YR HOMECHOICE PR APD SYSTEM (B)(4)