BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TINA SINGLE PUMP NIBP LCD

    MDR report key: 1212467 · Received October 29, 2008

    Report

    Report Number
    1423500-2007-88866
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    June 20, 2007
    Report Date
    June 21, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKP
    PMA / PMN Number
    K910215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED IN ACCORDANCE WITH INSTRUCTIONS FROM THE FDA TO ADDRESS A MANUFACTURER REPORT SEQUENCE NUMBER ISSUE THAT OCCURRED WHEN THIS MDR OR SUPPLEMENT WAS ORIGINALLY SUBMITTED TO THE FDA JULY 19, 2007. ON 06-25-07, THE NURSE FAXED THE RUN SHEET AND HER EVENT DESCRIPTION TO BAXTER PRODUCT SURVEILLANCE. THIS INFORMATION HAS BEEN FORWARDED TO BAXTER ENGINEERING AND TO BAXTER SERVICE FOR REVIEW. THE NURSE'S EVENT DESCRIPTION: NURSE REPORTS MACHINE FAILED DURING DIALYSIS MODE. REPORTS TMP PRESSURE GOING UP AND DOWN. SOME TMP READINGS WERE -500. IT WAS 25 MINUTES INTO PATIENT'S TREATMENT, HAD TO STOP TREATMENT AND DIALYZE PATIENT USING A DIFFERENT MACHINE. THE NURSE NOTES ALSO INDICATED THAT DR. WAS MADE AWARE OF OF THE PROBLEMS AND BAXTER WAS NOTIFIED. SEE MEDWATCH 1423500-2007-53. FACILITY REPORTED SAME ISSUE.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY:(PRODUCT EVALUATION): THE FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND WAS ASSISTED BY THE AREA SERVICE MANAGER ON THIS SERVICE CALL. TOGETHER THEY COULD NOT REPRODUCE THE PROBLEM. THE FSE REPLACED THE COMPONENTS WHAT WOULD MOST LIKELY CAUSE THE REPORTED PROBLEMS UF CONTROL PCB AND EPROM, I/O CONTROL PCB AND EPROM AND DIALYSATE PRESSURE TRANSDUCER WERE REPLACED. FUNCTIONAL CHECKS AND A SIMULATED PATIENT TREATMENT WAS RUN WITH NO PROBLEMS. THE FOLLOWING MORNING, THE AREA SERVICE MANGER WENT TO THE CLINIC. HE OBSERVED THE MACHINE DURING TWO PATIENT TREATMENTS WITH NO ISSUES OR ALARMS. IT WAS REPORTED TO THE AREA SERVICE MANAGER THAT BEFORE HE HAD ARRIVED, THE NURSE HAD PROBLEMS NOT RELATED TO ISSUES WHICH THE FIELD SERVICE STAFF HAD TRIED TO ADDRESS, BUT DURING CHANGEOVER AND SECOND RUN, ALL WENT WELL.

    Description of Event or Problem · 1

    A NURSE AT THE FACILITY REPORTED THAT THE MACHINE BEEPS AND THE DISPLAY READS: UF REMOVED TOO MUCH 8.30. THERE WAS NO PATIENT INJURY AND THERE WAS NO MEDICAL INTERVENTION. THIS OCCURRED DURING A PATIENT TREATMENT. ON 06-21-07, A FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND INSPECTED THE MACHINE. THE FSE WAS TOLD BY THE NURSE THAT THE TMP WAS VERY NEGATIVE. SHE ALSO REQUESTED THAT THE FSE TEST THE DEVICE WITH BLOOD LINES, DIALYZER AND SALINE JUST LIKE A TREATMENT. THE FSE DID A TREATMENT FOR ONE HOUR WITH A GOAL OF 1.0 L. AT THE END OF THE TREATMENT WITH NO ALARMS THE UF WAS 1.0 L. THE FSE CREATED PRESSURE CHANGES AND INCREASED AND DECREASED THE TREATMENT TIME AND THE TMP TRACKED THE WAY IT SHOULD. ALL SYSTEMS FUNCTION PER MANUFACTURES SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TINA SINGLE PUMP NIBP LCD 78FKP FKP BAXTER HEALTHCARE S1000L3P N/A

    Patients

    Seq Age Sex Outcome Treatment
    1