BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1941460 · Received December 29, 2010

    Report

    Report Number
    1423500-2010-07373
    Event Type
    Malfunction
    Date Received
    December 29, 2010
    Date of Event
    December 5, 2010
    Report Date
    December 5, 2010
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS AN ALLEGATION AGAINST THE CASSETTE; HOWEVER, SINCE THE PRODUCT CODE IS UNKNOWN AT THIS TIME, THERE WILL NOT BE A US 510K NUMBER PROVIDED IN THIS INITIAL REPORT. THIS REPORT IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR 2240 (AIR IN SET). THE REPORTED CONDITION WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE ALARM WAS NOT DETERMINED. A BATCH REVIEW WAS NOT PERFORMED BECAUSE LOT INFORMATION WAS UNKNOWN. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A BAXTER (B)(6) HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SUPPORT TO REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED DURING DWELL 6/7. THE HP STATED SHE WAS CONNECTED TO THE DEVICE AT THE TIME OF THE ALARM AND HAD NOT DISCONNECTED. THE HP CONFIRMED ALL BAGS WERE PROPERLY SPIKED AND CONNECTED AND NO PATIENT EXTENSION LINES WERE USED. THE HP ALSO CONFIRMED THERE WERE NO OPEN CLAMPS ON ANY UNUSED SUPPLY LINES AND NOTHING UNUSUAL WAS NOTED ABOUT THE SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED TO START THERAPY AGAIN USING NEW SUPPLIES. THE HP ADVISED SHE WOULD JUST END THERAPY FOR THE NIGHT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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 HOMECHOICE APD CYCLER ((B)(4))