BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1895094 · Received November 10, 2010

    Report

    Report Number
    1423500-2010-05562
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 16, 2010
    Report Date
    October 16, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LEAK (RESULTING IN A SYSTEM ERROR 2240) WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. A ROOT CAUSE WAS NOT IDENTIFIED. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE, AND THE LOT NUMBER WAS UNKNOWN. THEREFORE, NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DWELL 2. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) WITH TROUBLESHOOTING THE ALARM AND EXPLAINING THE ALARM. THE HP THEN REVEALED THAT DURING DWELL 2, HER CATHETER CAME APART AND LEAKED ONTO THE BED, AND THEN SHE RECEIVED THE SE 2240 ALARM. THE TSR ADVISED TO REPORT THE ALARM TO THE PERITONEAL DIALYSIS NURSE THE NEXT MORNING. THE HP WOULD FINISH THAT NIGHT'S THERAPY MANUALLY. DURING A FOLLOW UP WITH THE NURSE, IT WAS REVEALED THAT THE SEPARATION HAD OCCURRED BETWEEN THE CATHETER AND TRANSFER SET. THE NURSE STATED THAT THE HP NOTIFIED THEM OF THE ISSUE, AND THAT THE HP IMMEDIATELY PUT A NEW MINI CAP ON. PER NURSE, THE HP USED A PLASTIC CATHETER ADAPTER (PRODUCT CODE AND BRAND UNKNOWN). THIS EVENT OCCURRED DURING SLEEP. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR