BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 1000

    MDR report key: 2231763 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11587
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDI
    PMA / PMN Number
    K970446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED ONE TINA SINGLE PUMP NIBP LCD, SERIAL # (B)(4), PRODUCT CODE S1000L3P "SALINE DETECTOR: BLOOD DETECTED" ALARMS AT THE TERMINATION OF DIALYSIS TREATMENT. THE PROCESS STEP WAS DURING USE, THEREFORE THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE PATIENT OUTCOME IS UNKNOWN. THE BAXTER FIELD TECHNICIAN DETERMINED THE PROBLEM WAS 'PROBLEM WAS THE AIR DETECTOR AND REPLACED IT'. THIS CONFIRMS THE COMPLAINT. THE BAXTER FIELD TECHNICIAN DETERMINED THE ASSIGNABLE CAUSE 'A FAULTY AIR DETECTOR'.

    Additional Manufacturer Narrative · 1

    (B)(4). THE BAXTER FIELD SERVICE TECHNICIAN SERVICED THE DEVICE ONSITE, THEREFOR 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 PATIENT CONTACTED BAXTER (B)(4) TO REPORT AN ISSUE WITH A TINA HEMODIALYSIS MACHINE. THE PATIENT REPORTS HAVING A "SALINE DETECTOR: BLOOD DETECTED" ALARM AT THE TERMINATION OF DIALYSIS TREATMENT. THE BAXTER SERVICE TECHNICIAN MADE ARRANGEMENTS TO GO ONSITE TO EVALUATE THE DEVICE. THE PROCESS STEP WAS DURING USE, THEREFORE THERE WAS PATIENT INVOLVEMENT. ANY REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION IS UNKNOWN.

    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 - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1