BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2141090 · Received June 27, 2011

    Report

    Report Number
    1423500-2011-08381
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 4, 2011
    Report Date
    June 4, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE SE 2240 WAS DUE TO A SUPPLY BAG DISCONNECTING. LOT INFORMATION IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT COMPLETED. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR A USE/USER ERROR IDENTIFIED IN THIS INCIDENT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER'S AFTER HOURS CALL SERVICE THAT THE HOMECHOICE (HC) MACHINE SOUNDED A SYSTEM ERROR 2240 ALARM DURING DWELL 5 OF 5. THE PATIENT WAS CONNECTED TO THE MACHINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) DETERMINED THAT LAST FILL BAG BECAME PARTIALLY DETACHED FROM SET UP CAUSING THE ALARM. THE TSR ASSISTED THE PATIENT TO CLEAR THE ALARM TO END THERAPY AND CONTACT THE PERITONEAL DIALYSIS RENAL NURSE FOR DIRECTION REGARDING THE EXTRONEAL BAG THAT WAS NOT INFUSED. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE PRO