BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1830340 · Received September 10, 2010

    Report

    Report Number
    1423500-2010-03335
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240. THE REPORT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED FROM BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE SE 2240 WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE SUPPLY BAG FELL AND DISCONNECTED. THE PATIENT STATED THAT THE SUPPLY BAG FELL AND DISCONNECTED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. 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; LOT INFORMATION IS UNKNOWN AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DWELL 1. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP. THE HP STATED THAT THE SUPPLY BAG FELL AND DISCONNECTED. THE TSR ADVISED THE HP TO INFORM THE PERITONEAL DIALYSIS NURSE (PDRN) ABOUT THE ALARM. THE HP STATED SHE WAS TRAVELING WITHOUT ANY MANUAL SUPPLIES. THE HP CONFIRMED SHE WOULD ASK HER PDRN FOR FURTHER ADVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. 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 70 YR