BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1761335 · Received July 19, 2010

    Report

    Report Number
    1423500-2010-01542
    Event Type
    Malfunction
    Date Received
    July 19, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY NECESSARY SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR AN OVERPRIME WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. A BATCH REVIEW WAS PERFORMED ON THE ASSOCIATED LOT (H10D23077) WITH NO ISSUES NOTED. THERE WAS NOT ENOUGH DATA WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE; THEREFORE THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP)'S CAREGIVER (CG) CONTACTED BAXTER TO REPORT LEAKING ON THE CASSETTE FROM THE WHERE THE PLUNGER IS, ON THE FILL LINE DURING PRIMING. THE CG ADDED THAT THE LEAKING STOPS WHEN SHE PUSHED DOWN ON THE PLUNGER. THE EVENT DATE WAS UNKNOWN. NO INJURY WAS REPORTED DURING THE INITIAL REPORT. DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE TO THE NURSE ON (B)(6) 2010 REGARDING THE LEAK, IT WAS REVEALED THAT THEY HAD THE HP AND CG COME TO THE CLINIC AND WERE OBSERVED PERFORMING SETUP FOR THERAPY. PER NURSE, THEY WERE PERFORMING THE SETUP APPROPRIATELY, AND ADDED THAT IT WAS JUST SOME OVER-PRIMING AND THAT WAS IT. THIS WRITER EXPLAINED THE NURSE, THE NEED FOR INVESTIGATION OF OVER-PRIMING. THE NURSE UNDERSTOOD, AND REPORTED THAT HP IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. THE NURSE DID NOT HAVE INFORMATION ABOUT THE SAMPLE AVAILABILITY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED. PRODUCT SURVEILLANCE CONTACTED THE CG ON (B)(4) 2010 REGARDING THE CASSETTE LEAKS. THE CG EXPLAINED THAT DURING PRIMING ONLY, THE FLUID OVERFLOWED FROM THE TOP OF THE LINE, AND THE CG ADDED THAT SHE JUST CLAMPS THE LINE TO STOP IT. PER CG, THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT, AND THAT SHE DID NOT NOTICE ANY DEFECTS ON THE CASSETTES EITHER. THE CG STATED THAT SHE HAS ALREADY DISCUSSED THE ISSUE WITH THE NURSE. THIS WRITER ADVISED THE CG TO CONTACT THE NURSE FOR ADVICE ON APPROPRIATELY SETTING-UP THE HEIGHT OF THE TUBING AND HC CYCLER TO AVOID THE "OVERFLOWING" DURING PRIMING. THE CG AGREED. THE CG STATED THAT SHE HAS ALREADY DISCARDED THE CASSETTES, AND MOVED ON TO A DIFFERENT BOX OF SUPPLIES, THEREFORE, WAS UNABLE TO PROVIDE THE LOT NUMBERS. PER CG, HP IS DOING FINE AND CONTINUING THERAPY. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THIS TIME. NO FURTHER INFORMATION WAS PROVIDED.

    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 H10D23077

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR