BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U1105 S1000 TINA HD WITH NIBP

    MDR report key: 1920285 · Received December 10, 2010

    Report

    Report Number
    1423500-2010-06757
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDI
    PMA / PMN Number
    K970446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORTED CONDITION OF A WET TRANSDUCER PROTECTOR WAS RECEIVED, EVALUATED, AND RESOLVED/CORRECTED BY A BAXTER FIELD TECHNICIAN. THE COMPLAINT WAS RESOLVED BY CONFIRMING THAT THERE WAS NO CONTAMINATION AT THE VENOUS PORT. THE ASSIGNABLE CAUSE WAS THE WET HYDROPHILIC FILTER ON THE TUBING SET. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL BE SERVICED ONSITE BY A BAXTER FIELD SERVICE ENGINEER. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    (B)(4) TECHNICAL SERVICES (CTS) RECEIVED A TELEPHONE CALL IN WHICH A CUSTOMER REPORTED AN ISSUE WITH ONE S1000 TINA HEMODIALYSIS MACHINE. THE CUSTOMER REPORTED THAT THE DEVICE HAS A WET TRANSDUCER PROTECTOR. THE FIELD SERVICE REP WAS NOTIFIED TO GO ONSITE TO REPAIR THE DEVICE. AS SUCH, THE DEVICE WILL NOT BE RETURNED TO CTS FOR EVALUATION. THE PROCESS STEP AND ANY REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U1105 S1000 TINA HD WITH NIBP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1