BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1883601 · Received October 26, 2010

    Report

    Report Number
    1423500-2010-04946
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED TO BAXTER, THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE HOME PATIENT (HP)'S WIFE REVEALED THAT THE ISSUE WAS RESOLVED, AND THAT IT WAS CAUSED BY SOMETHING THEY HAD NOT DONE RIGHT. THE WIFE CONFIRMED THAT THERE WERE NO DEFECTS ON THE SUPPLIES. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS 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).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING FILL 6 OF 7. THE HOME PATIENT (HP) HAD TURNED OFF THE HC CYCLER. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED WITH TROUBLESHOOTING THE ALARM AND ADVISING TO CONTACT THE NURSE. THE HP WOULD COMPLETE THERAPY WITH MANUAL BAGS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE HP'S WIFE REGARDING THE ALARM, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED, AND THAT IT WAS CAUSED BY SOMETHING THEY HAD NOT DONE RIGHT. THE WIFE CONFIRMED THAT THERE WERE NO DEFECTS ON THE SUPPLIES. THE WIFE ADDED THAT THE HP DID HAVE PAIN IN SHOULDER FOLLOWING THIS EVENT. THE WIFE VERIFIED THAT SHE HAD DISCUSSED THE ALARM AND THE SHOULDER PAIN ISSUE WITH THE NURSE. PER WIFE, THEY WERE RE-TRAINED, AND THE PAIN ISSUE WAS RESOLVED USING HEATING PADS. PER WIFE, THE HP IS DOING FINE AND CONTINUING THERAPY. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED.

    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 40 YR