BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2192495 · Received August 5, 2011

    Report

    Report Number
    1423500-2011-10310
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 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). THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION, THEREFORE, THE SAMPLE WAS NOT REQUESTED AND A BATCH REVIEW WILL NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF A SYSTEM ERROR 2240 ALARM WAS CONFIRMED AND THE CAUSE WAS IDENTIFIED AS THE PATIENT LEAVING A CLAMP OPEN ON AN UNUSED SUPPLY LINE, BASED ON INFORMATION PROVIDED BY THE PATIENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (TSC) REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HOME PATIENT (HP) CHECKED THE LINES AND BAGS. THE HP FOUND THAT AN UNUSED SUPPLY LINE CLAMP WAS OPEN. THE TSR REVIEWED PROPER SETUP PROCEDURES. THE HP HAD ALREADY CYCLED POWER TO CLEAR SYSTEM ERROR (SE) 2240. THE TSR HAD HP DISCONNECT USING ASEPTIC TECHNIQUE. THE HP TO NOTIFY PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OF MISSED THERAPY. THE HP ENDED THERAPY. THERE WAS PATIENT INVOLVEMENT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) ON (B)(6) 2011 REGARDING THE SYSTEM ERROR 2240 ALARM. THE HOME PATIENT (HP) STATED THAT THE ISSUE WAS RESOLVED BY STARTING OVER WITH NEW SUPPLIES. THE HP SAID THAT THE CAUSE OF THE ALARM WAS DUE TO LEAVING A CLAMP ON AN UNUSED LINE OPEN. THE HP VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. PER HP, SHE DID NOT RECEIVE ANY INJURY OR MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT. THE HP STATED THAT SHE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THE HP STATED THAT SHE HAD DISCARDED THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBERS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. 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 37 YR HOMECHOICE