BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1953298 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00309
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 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 FOR A LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW CANNOT BE PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    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 PATIENT CONTACTED (B)(6) REGARDING ASSISTANCE WITH A LOW DRAIN VOLUME ALARM WHILE USING THE HOMECHOICE (HC) DURING THERAPY, IN THE INITIAL DRAIN CYCLE. (B)(4) REVIEWED THE DRAIN VOLUME (46ML) AND THE LAST FILL VOLUME (500ML) AND ASKED THE PATIENT IF SHE KNEW WHEN SHE WAS EMPTY. THE PATIENT SAID YES, SHE GETS DRAIN PAINS. (B)(4) THEN ASKED THE PATIENT IF SHE WAS EMPTY AND THE PATIENT SAID NO. THE PATIENT STATED THAT SHE SAW AN AIR BUBBLE IN THE PATIENT LINE. (B)(4) HAD THE PATIENT START THE DRAIN TO DRAIN MORE SOLUTION, BUT THE PATIENT WAS UNABLE TO. THE PATIENT STATED SHE WANTED TO START OVER WITH NEW SUPPLIES AND (B)(4) HAD THEM CYCLE POWER AND DISCONNECT. (B)(4) THEN ASSISTED WITH ENDING THERAPY AND REMOVING THE DISPOSABLE SET. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO EXPLAINED SHE DID NOT KNOW WHAT MAY HAVE CAUSED THERE TO BE AIR IN THE PATIENT LINE. THE PATIENT STATED SHE PRIMED THE LINE COMPLETELY BEFORE CONNECTING. THE PATIENT STATED SHE WAS ABLE TO RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)