BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1971977 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01127
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 7, 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 SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS NOT KNOWN BY THE PATIENT, THEREFORE DEVICE EVALUATION CANNOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO THE LACK OF A SAMPLE; THEREFORE, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. THE LOT INFORMATION WAS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT PERFORMED. REVIEW OF THE LABELING REVEALS THE HOMECHOICE APD SYSTEMS AT-HOME GUIDE CONTAINS SUFFICIENT LABELING FOR THE USER ERROR (ADDING ANOTHER SUPPLY BAG) IN THIS COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER REGARDING A SYSTEM ERROR 2240 ALARM THAT APPEARED ON THE HOME CHOICE (HC) DURING DWELL 1 OF 4. THE HP STATED SHE EXPERIENCED THE SAME ERROR EARLIER. (B)(4) HAD THE HOME PATIENT (HP) CLOSE THE CLAMPS, DISCONNECT, AND CYCLE THE POWER TWICE TO CLEAR THE ERROR. THE (B)(4) ASSISTED THE HP WITH GETTING THE SET OUT. (B)(4) ASKED THE HP IF SHE STARTED OVER WITH A NEW SET WHEN SHE HAD THE ALARM EARLIER. THE HP SAID NO. THE HP STATED SHE JUST ADDED ANOTHER BAG TO THE HC BECAUSE THE SUPPLY BAG WAS EMPTY. (B)(4) RECOMMENDED THE HP CONTACT THE REGISTERED NURSE (RN) ABOUT THE ALARM. THE HC WAS OPERATIONAL AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THE PATIENT WAS INVOLVED, BUT THERE WAS NO SERIOUS INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)