BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1904871 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-05971
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING DWELL 8 OF 10. THE HP STATED THE HEATER BAG WAS CONNECTED VERY LOOSELY AND THE HEATER BAG HAD A LOT OF AIR IN IT. THE TSR ASSISTED THE HP TO CYCLE POWER TO CLEAR THE ALARM. THE TSR EXPLAINED THE ALARM AND THAT THE HP NEEDED TO START OVER WITH NEW SUPPLIES. THE HP STATED SHE WOULD CALL HER NURSE FIRST TO SEE IF THE NURSE WANTED HER TO START OVER TONIGHT. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE CG. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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