BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1901300 · Received November 17, 2010

    Report

    Report Number
    1423500-2010-05871
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 23, 2010
    Report Date
    October 23, 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). 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). THE LOT NUMBER AND SAMPLE AVAILABILITY ARE UNKNOWN AT THIS TIME. BAXTER IS ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION. 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 FOR A CHECK LINES AND BAGS ALARM WAS NOT CONFIRMED. THE PRODUCT WAS NOT RETURNED TO BAXTER FOR EVALUATION. IT WAS NOT POSSIBLE TO REVIEW MANUFACTURING RECORDS FOR THE LOT BECAUSE THE LOT NUMBER IS UNKNOWN. A CAUSE OF THE ALARM 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 THROUGH (B)(4)..

    Description of Event or Problem · 1

    PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S (HP) CARE GIVER (CG). THE CG STATED THAT SHE DID NOT NOTICE VISUALLY THAT THERE WAS ANYTHING WRONG WITH THE SUPPLIES BUT STATED THAT SHE FELT THAT THERE MAY HAVE BEEN AN ISSUE WITH ONE OF THE DRAIN LINES BECAUSE WHEN THEY CHANGED OUT THE DRAIN LINES, EVERYTHING WORKED FINE. THE CG STATED THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING A CHECK LINES & BAGS ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING PRIME, THE HOME PATIENT (HP)'S CAREGIVER (CG) REVEALED THAT WHEN SHE DISCONNECTED THE DRAIN LINE EXTENSIONS, SHE FELT A RELEASE OF AIR PRESSURE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE CG WITH PRIMING, AND THE CG WOULD ATTACH 2 NEW DRAIN LINE EXTENSIONS, AND HP WAS READY TO BEGIN THE THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    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 41 YR