BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1800426 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02517
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 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 REPORT OF A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE CG STATED THE HOME PATIENT (HP) WAS IN THE HOSPITAL AND WHEN THE ALARM OCCURRED THE NURSE HAD TURNED THE MACHINE OFF. THE CG STATED THE NURSE THEN TURNED THE MACHINE OFF COMPLETELY. THE PATIENT WAS HOSPITALIZED FOR A DIAGNOSIS NOT RELATED TO PD. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. LABEL REVIEW WAS NOT PERFORMED NO USER ERROR WAS SUSPECTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOWUP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A PATIENT CONTACT GLOBAL TECHNICAL SERVICES (GTS) REGARDING A SYSTEM ERROR 2240 THAT APPEARED ON THE HC DURING A DRAIN CYCLE. THE PATIENT STATED THEY WOKE UP AND NOTICED THAT THE PATIENT LINE HAD INADVERTENTLY SEPARATED FROM THE TRANSFER SET. GTS HAD THE PATIENT CYCLE POWER TWICE TO CLEAR THE ERROR TO THE "PRESS GO TO START" PROMPT. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET AND ADVISED THE PATIENT TO NOTIFY THEIR NURSE. GTS INSTRUCTED THE PATIENT TO DISCARD THE SUPPLIES AND FINISH THEIR LAST CYCLE WITH A MANUAL EXCHANGE.

    Description of Event or Problem · 1

    A CAREGIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM AND SE 2367 THAT OCCURRED ON THE HOMECHOICE (HC) UNIT. THE CG STATED THE HOME PATIENT (HP) WAS IN THE HOSPITAL AND WHEN THE ALARM OCCURRED THE NURSE HAD TURNED THE MACHINE OFF/ON AND THEN RECEIVED THE SE 2367 ALARM. THE CG STATED THE NURSE THEN TURNED THE MACHINE OFF COMPLETELY. THE CG STATED WHEN SHE ARRIVED AT THE HOSPITAL, SHE TURNED THE MACHINE ON AND THE DISPLAY READ "PRESS GO TO START." THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE CG TO DISCONNECT THE HP AND ADVISED THAT SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP. THE CG STATED THE HP WOULD COMPLETE THERAPY WITH A MANUAL EXCHANGE. ON (B)(6) 2010, THE HP'S PERITONEAL DIALYSIS NURSE (PDRN) SPOKE WITH BAXTER HOMECARE SERVICES. THE PDRN REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR A DIAGNOSIS OF LOW BLOOD PRESSURE ON (B)(6) 2010. THE HP WAS DISCHARGED FROM THE HOSPITAL (B)(6) 2010. THE PDRN REPORTED THE HP IS RECOVERING AND CONTINUING WITH THERAPY ON THE HC UNIT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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 80 YR