BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2101409 · Received May 24, 2011

    Report

    Report Number
    1423500-2011-06432
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) THAT OCCURRED DURING DRAIN 12 OF 14 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. 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

    THE CAREGIVER (CG) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) MACHINE DURING DRAIN 12 OF 14. THE CG STATED THE HOME PATIENT'S (HP) CATHETER BECAME DISCONNECTED AND THE PATIENT'S MOTHER TOOK HIM TO THE HOSPITAL. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE SE 2240 ALARM INDICATES AIR ENTERED SET UP AND FURTHER ASSISTED THE CG TO CYCLE POWER TO CLEAR THE ALARM. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE HP'S NURSE WHO STATED THE TRANSFER SET SEPARATED FROM THE CATHETER ADAPTER. THE NURSE CONFIRMED THE TRANSFER SET WAS CHANGED OUT AND EVERYTHING WAS FINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO