BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2200418 · Received August 11, 2011

    Report

    Report Number
    1423500-2011-10533
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 19, 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). THIS COMPLAINT FOR LOW DRAIN VOLUME ALARM WAS CONFIRMED. THE ROOT CAUSE WAS AIR IN THE PATIENT LINE. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4).SINCE THE LOT NUMBER WAS UNKNOWN, A BATCH REVIEW CANNOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR WHEN ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A LOW DRAIN VOLUME ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING DRAIN 3 OF 4. THE TSR NOTED THAT THERE WAS AIR IN THE PATIENT LINE AND THE MACHINE WAS ELEVATED ABOVE THE PATIENT. THE TSR SUGGESTED TO LET THE RN KNOW ABOUT THE ALARM AND AIR IN THE LINE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) REGARDING THE AIR IN LINE. THE HP DID NOT RECALL THE EVENT AND WAS NOT SURE IF THERE WAS AIR IN THE LINE ON THAT SPECIFIC DAY. THE HP STATED THEY DID NOT HAVE ANY OF THE SAMPLES FROM THAT EVENT AND DID NOT KNOW THE LOT NUMBERS. THE HP STATED THEY WERE ABLE TO GET PAST THE ALARM OVER THE PHONE THAT DAY. THE HP STATED THEY DID NOT HAVE ANY INJURY OR MEDICAL INTERVENTION.

    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 51 YR HOMECHOICE