BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1823773 · Received September 2, 2010

    Report

    Report Number
    1423500-2010-03115
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 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). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADVERSE EVENT WAS REPORTED AS A RESULT OF THIS ISSUE. THIS REPORT OF A SE 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 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).

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING DWELL 5 OF 6. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP TO CLOSE ALL THE CLAMPS AND TRANSFER SET. THE TSR EXPLAINED SE 2240 INDICATES A LARGE AMOUNT OF AIR HAS ENTERED SETUP. THE HP STATED HE WAS UNSURE WHY THE HC ALARMED WITH SE 2240. THE HP CONFIRMED HE DID NOT DISCONNECT, THE SPARE LINE CLAMP WAS CLOSED, AND THE BAGS WERE CONNECTED. THE TSR ADVISED THE HP TO REPORT INCIDENT TO HIS PERITONEAL DIALYSIS NURSE. THE HP STATED HE WOULD FINISH THERAPY MANUALLY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT SHE UNDERWENT TOTAL HIP ARTHROPLASTY ON (B)(6) 2006. SUBSEQUENTLY, PATIENT BEGAN TO EXPERIENCE PAIN AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2008. THICK HYPERTROPHIC FIBROUS SCAR TISSUE WAS REMOVED AND THE MODULAR HEAD AND TAPER ADAPTER WERE REMOVED AND REPLACED. IT WAS FURTHER CONVEYED THAT THE PATHOLOGY REPORT FOUND REACTIVE CHRONICALLY INFLAMED SYNOVIUM.

    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 73 YR