BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1920351 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06771
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    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 IS NOT AVAILABLE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A CONNECTION ISSUE - DISCONNECTION OF A SUPPLY BAG WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE TO IDENTIFY THE ROOT CAUSE; THEREFORE THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) REGARDING ASSISTANCE SETTING UP THE HOME CHOICE (HC) DURING PRIME. THE HOME PATIENT (HP) STATED THAT THE SPIKE CAME OUT OF THE FINAL LINE IN THE PRIMING. (B)(4) ASSISTED THE HP TO CYCLE POWER OFF AND ON. (B)(4) EXPLAINED TO THE HP TO GET ANOTHER FINAL BAG AND CONNECT THE BAG TO THE FINAL LINE AND PRESS GO. THE HP STATED THAT THE HC WAS NOW PRIMING AS NORMAL. THE HC WAS OPERATIONAL AND A SWAP OF THE DEVICE WAS NOT NECESSARY. 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 80 YR PD CYCLER