BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL-DISPOSABLE

    MDR report key: 1953025 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00262
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. A BATCH REVIEW WAS NOT PERFORMED AS LOT INFORMATION WAS UNKNOWN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET. THE HOME PATIENT (HP) STATED THAT SHE HAD DISCONNECTED TO USE THE RESTROOM THEN RECONNECTED WHEN SHE HEARD THE ALARM. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR A USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED. THE PRODUCT CODE IS UNKNOWN; THEREFORE, THE 510K NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 ALARM (INDICATING AIR IN THE SET) ON THE HOMECHOICE (HC) DEVICE DURING INITIAL DRAIN 1. THE HOMEPATIENT (HP) STATED SHE HAD DISCONNECTED TO USE THE RESTROOM THEN RECONNECTED WHEN SHE HEARD THE ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND ADVISED THE HP TO DISCARD SUPPLIES AND START OVER WITH NEW. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1