BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2090385 · Received May 16, 2011

    Report

    Report Number
    1423500-2011-06053
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 22, 2011
    Report Date
    April 22, 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 IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THERE WAS NOT ENOUGH DATA WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE OF THE AIR. 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

    THIS REPORT IS FOR CUSTOMER REPORTING AIR IN THE LINE. THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT CHECK PATIENT LINE WHICH OCCURRED ON HOMECHOICE (HC) DURING USE DURING INITIAL DRAIN. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CLOSE AND OPEN TRANSFER SET 3 TIMES, MOVE CLAMP AND RUB LINE, PULL UP ONLINES, CHECK LINES FOR FIBRIN OR AIR. THE HP STATED THAT THERE WAS AIR IN THE LINE. THE TSR EXPLAINED THAT THE HP WILL NEED TO END THERAPY AND START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. WRITER CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM. THE HP STATED THAT THERE WAS NO ISSUE WITH ANY OF THE DISPOSABLE ITEMS AND THERE WAS A FLAW WITH THE MACHINE. THE HP STATED THAT THE FLAW IN THE MACHINE IS WHAT CAUSED THE AIR TO ENTER THE LINES. THE HP STATED THAT THEY GOT A NEW MACHINE SINCE THEN AND NOW THEIR THERAPY WAS GOING FINE. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    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 75 YR