BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2090257 · Received May 16, 2011

    Report

    Report Number
    1423500-2011-05999
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED. AT THIS TIME, THIS REPORT IS BEING TREATED AS AN ALLEGATION AGAINST THE CASSETTE. SINCE THE PRODUCT CODE IS UNKNOWN, THERE WILL NOT BE A 510K NUMBER PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL MEDWATCH REPORT FOR SE 2240 ALLEGED AGAINST THE CASSETTE WAS SUBMITTED IN ERROR IN THIS MDR REPORT NUMBER 1423500-2011-05999. ALL THE NECESSARY ADDITIONAL INFORMATION RELATED TO THIS EVENT HAS BEEN SUBMITTED ON (B)(4) 2012 WITHIN THE MDR REPORT NUMBER 1423500-2012-01376.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SYSTEM ERROR 2240 WHICH OCCURRED ON THE HOMECHOICE MACHINE DURING DWELL 3 OF 4. THE CUSTOMER STATED THERE WAS A LEAK; HOWEVER, THE LEAK AREA WAS NOT IDENTIFIED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE PRO