BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL-DISPOSABLE

    MDR report key: 1960218 · Received January 13, 2011

    Report

    Report Number
    1423500-2011-00551
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 19, 2010
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED CONDITION OF A LEAK WAS NOT CONFIRMED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS DUE TO THE SUPPLY BAG FALLING AND DISCONNECTING. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED. THE PRODUCT CODE IS UNKNOWN; THEREFORE, THE 510K NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    THIS IS A CASE REPORT RECEIVED THROUGH BAXTER'S AFTERHOURS CALL SERVICE. A CUSTOMER REPORTED THAT THE HOMECHOICE MACHINE SOUNDED A SERVICE ALARM DURING FILL 2 OF 7. THE PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF ALARM. THE TECHNICAL SERVICE REPRESENTATIVE ASKED THE PATIENT TO START OVER WITH NEW SUPPLIES AND THE PATIENT REPLIED THAT HE DID NOT KNOW THAT. A NURSE HAD SET-UP THE HOMECHOICE BUT THE BAGS FELL OVER TWICE BEFORE BUT WERE NOT LEAKING. HOWEVER IN THIS INSTANCE THE BAG FELL AND STARTED LEAKING. THE HOMEPATIENT WAS ADVISED TO CALL THE CLINIC FIRST THING IN THE MORNING. THE HOMECHOICE IS RESET FOR A NEW THERAPY. NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED. NO SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1