BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2212289 · Received August 15, 2011

    Report

    Report Number
    1423500-2011-10727
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    January 1, 2011
    Report Date
    July 19, 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). THE LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBER: H11E04131 AND H11D27069 WITH NO DEFECTS NOTED DURING THE MANUFACTURE OF THESE LOTS RELATED TO THE REPORTED CONDITION. THE COMPLAINT WAS NOT CONFIRMED FOR CONNECTION ISSUE. THE CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF CONNECTING AND DISCONNECTING SO MANY TIMES IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). THE PATIENT WAS CONNECTING AND DISCONNECTING SO MANY TIMES THAT THE MACHINE MALFUNCTIONED AS A RESULT. THE PATIENT REPORTED HAVING PERITONITIS, HOWEVER, THE NURSE STATED THAT THE PATIENT DID NOT HAVE PERITONITIS. TREATMENT WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. AN OPINION OF CAUSALITY WAS NOT REPORTED. THE NURSE DECLINED TO PROVIDE FURTHER INFORMATION. NO FURTHER INFORMATION IS AVAILABLE.

    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 93 YR HOMECHOICE