BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1891406 · Received November 4, 2010

    Report

    Report Number
    1423500-2010-05266
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: PRODUCT SURVEILLANCE SPOKE WITH THE NURSE WHO CONFIRMED THAT THE PATIENT HAS RESUMED THERAPY WITHOUT FURTHER ISSUE. THE NURSE CONFIRMED NO SAMPLE WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) THAT OCCURRED DURING DRAIN 3 OF 7 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    THE NURSE(RN) FOR THE HOME PATIENT (HP) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 ALARM WHICH OCCURRED ON THE HOMECHOICE(HC) DURING DRAIN 3 OF 7. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE(TSR) EXPLAINED SYSTEM ERROR 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED THE SET UP. THE RN THEN DETECTED A LARGE AMOUNT OF AIR IN THE CASSETTE. THE TSR INSTRUCTED THE RN TO CYCLE POWER TO CLEAR THE ALARM. THE TSR ADVISED THE RN THAT THERAPY HAS ENDED AND TO START OVER WITH NEW SUPPLIES OR DO A MANUAL EXCHANGE. THE RN STATED THAT SHE WOULD FOLLOW UP WITH THE PERITONEAL DIALYSIS (PDRN) FOR FURTHER ORDERS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR