BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1951806 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00209
    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 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. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH RENQ-CAPA-(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE PATIENT'S THERAPY, IN THE INITIAL DRAIN CYCLE. (B)(4) HAD THE PATIENT CYCLE POWER AND END THERAPY. (B)(4) THEN HAD THE PATIENT DISCONNECT USING ASEPTIC TECHNIQUE AND REMOVE THE CASSETTE. THE PATIENT EXPLAINED SHE CONNECTED A PATIENT LINE EXTENSION PRIOR TO THE START OF PRIMING, BUT DID NOT CHECK THE PATIENT LINE TO VISUALLY VERIFY THE LINE WAS FULLY PRIMED BEFORE CONNECTING. THE PATIENT ELECTED TO START OVER WITH NEW SUPPLIES. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO EXPLAINED SHE DID NOT NOTE ANYTHING UNUSUAL AT THE TIME OF THE ERROR. THE PATIENT STATED THE LINES PRIMED FULLY, AND THAT SHE TRIED TO FIGURE OUT WHAT WAS WRONG WITH THE SETUP, BUT ENDED UP DISCARDING THE SUPPLIES. THE PATIENT INDICATED SHE WAS ABLE TO RESUME THERAPY WITHOUT ANY PROBLEMS. THE PATIENT ALSO CONTACTED HER DIALYSIS NURSE REGARDING THE ERROR. 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 53 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)