BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1830337 · Received September 10, 2010

    Report

    Report Number
    1423500-2010-03336
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 21, 2010
    Report Date
    August 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION; THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION; THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF AIR IN LINE. BASED UPON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE AIR IN TUBING WAS USER ERROR. THE PATIENT STATED SHE LEFT THE PATIENT LINE CLAMP CLOSED DURING PRIMING. THE AT HOME GUIDE INSTRUCTS USERS WHEN AND HOW TO PRIME THE CASSETTE, TO OPEN THE PATIENT LINE CLAMP FOR PRIMING, AND WARNS TO NOT CONTINUE THERAPY AFTER PRIME UNLESS THE FLUID LEVEL IS AT OR NEAR THE CONNECTOR AT THE END OF THE DISPOSABLE SET PATIENT LINE. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ALSO EXPLAINED TO THE PATIENT THAT THE CLAMP HAS TO BE OPEN ON THE PATIENT LINE IN THE PRIMING IN ORDER FOR THE LINE TO PRIME THE AIR OUT BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY AND LOT INFORMATION ARE UNKNOWN AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED (B)(4) REGARDING AIR IN THE PATIENT LINE DURING THERAPY ON THE HOMECHOICE (HC) UNIT. THE HP STATED THAT SHE DID NOT HAVE THE PATIENT LINE CLAMP OPEN DURING THE PRIMING AND SHE THINKS THERE WAS AIR IN THE PATIENT LINE. THE HP STATED SHE DISCONNECTED HERSELF IN DRAIN 1 OF 6 DUE TO HER SHOULDERS HURTING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE HP TO ALWAYS MAKE SURE THE CLAMP WAS OPEN ON THE PATIENT LINE. THE TSR ADVISED THE HP TO CALL HER NURSE TO ADVISE. THE HP STATED SHE WAS TOLD BY HER NURSE TO KEEP THE CLAMP ON THE PATIENT LINE CLOSED UNTIL SHE WAS READY TO CONNECT. THE TSR EXPLAINED TO THE HP THAT THE CLAMP HAS TO BE OPEN ON THE PATIENT LINE IN THE PRIMING IN ORDER FOR THE LINE TO PRIME THE AIR OUT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR