BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1875167 · Received October 19, 2010

    Report

    Report Number
    1423500-2010-04621
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 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). THIS COMPLAINT IS FOR A REPORT OF A PATIENT SPIKING A SUPPLY BAG WITH THE PULL RING STILL ON THE BAG. THIS COMPLAINT CANNOT BE CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE POTENTIAL USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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 LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME.A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(6) SERVICE CENTER REPORTING THAT SHE HAD SPIKED THE BAG WITH THE PULL RING STILL ON THE BAG, AND REQUESTED ASSISTANCE TO START OVER WITH NEW SUPPLIES ON THE HOMECHOICE (HC) MACHINE. THE HC MACHINE WAS AT STOPPED SETUP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) WITH TROUBLESHOOTING. THE HP STATED SHE WOULD START OVER WITH NEW SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE TO THE HOME PATIENT (HP) REGARDING THE USE ERROR, THE HP STATED SHE DID NOT REMEMBER THE EVENT; HOWEVER, THE HP ADDED THAT SHE USES THE LUER LOCK SUPPLIES NOW. PER HP, SHE IS FINE AND CONTINUING THERAPY. NO FURTHER INFORMATION WAS PROVIDED.

    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