BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2073166 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05207
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 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 THE SYSTEM ERROR 2240 (AIR IN LINE) 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) SAID HE DID NOT KNOW HOW AIR GOT INTO THE LINE AND HE DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES. THE BATCH REVIEW WAS PERFORMED ON POTENTIALLY ASSOCIATED LOT (H10J05080) WITH NO ISSUES NOTED. 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. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A REGISTERED NURSE (RN) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING USE. THE RN STATED THE HOME PATIENT (HP) EXPERIENCED THE ALARM DURING THE PREVIOUS NIGHT'S THERAPY AND CYCLED POWER TO CLEAR THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED A SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP, AND THAT NEW SUPPLIES NEEDED TO BE USED. THE RN UNDERSTOOD AND WOULD ADVISE THE HP. THE PATIENT WAS INVOLVED BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. A FOLLOW UP WAS MADE VIA PHONE CALL. THE HP SAID HE DID NOT KNOW HOW AIR GOT INTO THE LINE AND HE DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES. THE HP SAID HE RESUMED THERAPY WITHOUT COMPLICATIONS.

    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 H10J05080

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR HOMECHOICE