BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1896723 · Received November 10, 2010

    Report

    Report Number
    1423500-2010-05572
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 17, 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). PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A CHECK PATIENT LINE ALARM AND WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN, THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE PATIENT STATED THAT THERE IS AIR IN THE PATIENT LINE. 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.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING A CHECK PATIENT LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING INITIAL DRAIN, THE HOME PATIENT (HP) REVEALED THAT THERE WERE GAPS OF AIR IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH ENDING THERAPY ON THE HC CYCLER, SO THAT HE COULD START OVER WITH NEW SUPPLIES. THE HP TO SETUP WITH NEW SUPPLIES. DURING A FOLLOW UP WITH THE HP REGARDING THE AIR IN LINE, IT WAS REVEALED THAT THE ISSUE WAS RESOLVED, BUT HE DID NOT KNOW WHAT MIGHT HAVE CAUSED THE ALARM. THE HP VERIFIED THAT HE HAD DISCUSSED THE ISSUE WITH HIS NURSE, AND SHE WENT OVER THE PROPER PROCEDURE WITH HIM. THE HP CONFIRMED THAT HE HAD NOT NOTICED ANY LOOSE CONNECTIONS, DISCONNECTIONS OR DEFECTS ON THE SUPPLIES. THE HP DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP?S DIALYSIS PRODUCTS. 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 90 YR