BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2070063 · Received April 26, 2011

    Report

    Report Number
    1423500-2011-05067
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Date of Event
    April 7, 2011
    Report Date
    April 7, 2011
    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 NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR AN OVERPRIME WAS NOT CONFIRMED IN THE LAB DUE TO UNAVAILABLE SAMPLE. NO ROOT-CAUSE WAS DETERMINED. A BATCH REVIEW WAS NOT PERFORMED SINCE LOT NUMBER WAS NOT AVAILABLE. NO USER ERROR WAS SUSPECTED THEREFORE NO LABEL REVIEW WAS REQUIRED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A CHECK LINES AND BAGS ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING PRIME. DURING (B)(4) TROUBLESHOOTING, THE HP STATED THAT THE PATIENT LINE WAS DRIPPING. THE HP SUCCESSFULLY PRIMED THE PATIENT LINE. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE, AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE CAREGIVER WAS CONTACTED ON (B)(6) 2011. THE CAREGIVER STATED THAT THEY WERE STACKING THE SOLUTION BAGS ON TOP OF THE HOMECHOICE MACHINE WHICH WAS EXPLAINED BY THE CLINICAL EDUCATOR TO BE CAUSING THE OVER-PRIMING ISSUE. THE CAREGIVER STATED THAT THE ISSUE HAS BEEN RESOLVED. THE CAREGIVER STATED THAT THE HOME PATIENT DID NOT DEVELOP ANY ADVERSE REACTIONS OR REQUIRE ANY MEDICAL INTERVENTION. THE CAREGIVER STATED THE HOME PATIENT IS CURRENTLY PERFORMING THERAPY WITHOUT ANY COMPLICATIONS. THE CAREGIVER STATED THIS ISSUE HAD OCCURRED SEVERAL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR HOMECHOICE