BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 1000

    MDR report key: 2230704 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11537
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - MIAMI LAKES
    Product Code
    KDI
    PMA / PMN Number
    K970446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE OF DISPLAY CHANGED FROM 1L TO 11L REMOVED WAS CONFIRMED OVER THE PHONE BY GLOBAL TECHNICAL SERVICES AT THE TIME THE INCIDENT WAS REPORTED. THE ASSIGNABLE CAUSE FOR THE REPORTED ISSUE WAS DETERMINED TO BE THE UF/BP CONTROLLER BOARD.

    Additional Manufacturer Narrative · 1

    (B)(4). THE BIOMED AT THE FACILITY REPAIRED THE DEVICE, NO SAMPLE WAS RETURNED FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A BIOMED CONTACTED GLOBAL TECHNICAL SERVICE (GTS) TO REPORT THAT A TINA HEMODIALYSIS MACHINE THAT THE DEVICE DISPLAY JUST CHANGED FROM 1L TO 11L REMOVED. THE PATIENT WAS TAKEN OFF THE DEVICE AND WEIGHED. THE PATIENT ONLY HAD 1L REMOVED NOT 11L. THE PATIENT WAS PLACED ON A DIFFERENT MACHINE SO THERAPY COULD CONTINUE. THE BIOMED THEN CHECKED THE DEVICE AND FOUND THE ULTRAFILTRATION (UF) SYSTEM WAS OK AND NO OTHER PROBLEMS WERE NOTED. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FIELD SERVICE ENGINEER (FSE) ADVISED THE BIOMED TO CHANGE THE ULTRAFILTRATION (UF)/ BLOOD PUMP (BP) CONTROLLER PRINTED CIRCUIT BOARD (PCB). A FOLLOW UP WAS DONE. THE BIOMED STATED THE PATIENT WAS FINE AND CONTINUED THERAPY ON A DIFFERENT DEVICE. REPLACING THE ULTRAFILTRATION (UF)/ BLOOD PUMP (BP) CONTROLLER PRINTED CIRCUIT BOARD (PCB) RESOLVED THE ISSUE. NO INJURY OR MEDICAL INTERVENTION REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 1000 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - MIAMI LAKES

    Patients

    Seq Age Sex Outcome Treatment
    1