BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1903749 · Received November 20, 2010

    Report

    Report Number
    1423500-2010-06041
    Event Type
    Malfunction
    Date Received
    November 20, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CHECK HEATER LINE ALARM COULD NOT BE CONFIRMED IN THE LAB, BECAUSE THE SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. FROM THE DATA WITHIN THE COMPLAINT INFORMATION, THE ROOT CAUSE WAS NOT IDENTIFIED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING, A CHECK HEATER LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING FILL 1, THE HOME PATIENT (HP) DISCONNECTED THE HEATER BAG TO SEE IF SOLUTION WOULD FLOW FROM IT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) THEN ADVISED THE HP TO END THERAPY AND RESTART WITH ALL NEW SUPPLIES. THE HP STATED THAT HE WOULD USE MANUAL SUPPLIES FOR THERAPY THAT NIGHT. DURING A FOLLOW UP WITH THE HP REGARDING THE USE ERROR, IT WAS REVEALED THAT AFTER THE TSR EXPLAINED, THE HP REALIZED THAT HE WAS NOT SUPPOSED TO DISCONNECT THE BAGS DURING THERAPY AS IT MAY CAUSE A BREACH IN THE STERILE PATHWAY. THE HP CONFIRMED THAT HE DISCUSSED WITH NURSE ABOUT THIS, AND WILL NOT DISCONNECT BAGS DURING THERAPY AGAIN. THE HP VERIFIED THAT HE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. THE HP STATED THAT HE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. NO FURTHER INFORMATION WAS PROVIDED.

    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 71 YR