BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2080682 · Received May 6, 2011

    Report

    Report Number
    1423500-2011-05612
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 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 FOR EVALUATION, THEREFORE, BAXTER CANNOT DETERMINE THE ROOT CAUSE. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW WILL NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4).THIS REPORT FOR CHECK PATIENT LINE ALARM WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. 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 CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT RECEIVING CHECK PATIENT LINE ALARM WITH THE HOMECHOICE (HC) MACHINE DURING THE INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) AND HAD THE HP CLOSE / OPEN THE TRANSFER SET 3 TIMES, MOVE CLAMP, PULL UP ON LINES, AND CHECK LINES FOR FIBRIN OR AIR. THE HP STATED THAT THERE ARE SOME LARGE AIR BUBBLES IN THE LINE. THE TSR RECOMMENDED THAT HP END THERAPY AND START OVER WITH NEW SUPPLIES. TSR WALKED HP THROUGH ENDING THERAPY PROCEDURE. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011 REGARDING THE CHECK PATIENT LINE ALARM WITH AIR IN THE PATIENT LINE. THE HP STATED THAT THE ISSUE WAS RESOLVED, HOWEVER, THE CAUSE OF THE ALARM REMAINED UNKNOWN. THE HP SAID THAT HE PRIMED THE PATIENT LINE COMPLETELY BEFORE CONNECTING. THE HP VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. THE HP STATED THAT HE WAS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED.

    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 91 YR HOMECHOICE