BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1897025 · Received November 11, 2010

    Report

    Report Number
    1423500-2010-05650
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER PRODUCT SURVEILLANCE CONTACTED THE PATIENT. THE PATIENT STATED THAT THE SUPPLIES WERE DISCARDED AT THE TIME OF THE CALL. THE PATIENT REFUSED TO PROVIDE ANY FURTHER INFORMATION. NO LOT NUMBER OR COMPANION SAMPLES WERE AVAILABLE. THIS COMPLAINT A REPORT OF AIR IN THE PATIENT LINE WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; THEREFORE, THE ASSIGNABLE CAUSE WAS NOT DETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THIS INCIDENT WAS RESOLVED OVER THE PHONE USING THE CURRENT LABEL COPY. SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS REPORTED PROBLEM, BUT THERE IS NO ADVERSE TREND FOR THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A NURSE CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH WANTING TO MANUALLY DRAIN WHILE USING THE HOMECHOICE (HC) DURING FILL 1 OF 6. THE NURSE STATED THE PATIENT NEEDED TO DRAIN OUT, BUT THEY WERE UNABLE TO. THE NURSE ATTEMPTED TO MANUALLY DRAIN THE PATIENT, BUT NOTHING DRAINED OUT. THE NURSE STATED THE PATIENT HAD FILLED WITH SOLUTION ON A DIFFERENT SYSTEM, SO THERE WAS SOMETHING THAT NEEDED TO BE DRAINED OUT. THE NURSE STATED SHE ALSO NOTICED AIR BUBBLES IN THE PATIENT LINE. GTS HAD THE NURSE CYCLE POWER AND ADVISED THEM TO DISCONNECT THE PATIENT AND START OVER WITH NEW SUPPLIES. THE NURSE WAS UNFAMILIAR WITH THE HC AND REQUESTED ASSISTANCE GOING THROUGH THE SETUP PROCESS. GTS ASSISTED THE NURSE IN SETTING UP THE HC AND STARTING THE INITIAL DRAIN. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 56 YR