BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1890380 · Received November 3, 2010

    Report

    Report Number
    1423500-2010-05225
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 9, 2010
    Report Date
    October 9, 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). THE LOT NUMBER AND SAMPLE WILL NOT BE EVALUATED; HP HAS REGAINED KIDNEY FUNCTION AND IS NO LONGER ON PD THERAPY. 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 AIR IN LINE. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. PER THE COMPLAINT INFORMATION, THERE WAS AIR IN THE PATIENT LINE. THE ROOT CAUSE OF THE COMPLAINT IS NOT DETERMINED. 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.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING A LOW DRAIN VOLUME (LDV) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING INITIAL DRAIN, THE HOME PATIENT (HP) REVEALED THAT THERE WAS A LOT OF AIR IN THE PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE TSR WAS UNABLE TO BYPASS TO FILL 1 DUE TO AIR IN PATIENT LINE. THE TSR THEN ASSISTED THE HP TO END THERAPY. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW UP WITH THE HP'S NURSE AT THE NURSING HOME REGARDING THE AIR IN LINE, IT WAS REVEALED THAT THE HP WAS NOT ON PERITONEAL DIALYSIS (PD) THERAPY. THE NURSE DID NOT PROVIDE ANY FURTHER INFORMATION. DURING A FOLLOW-UP WITH THE HP PD NURSE, SHE STATED THAT HP DID NOT REPORT ANY AIR IN LINE ISSUE TO HER. THE NURSE THEN REVEALED THAT THE HP IS NO LONGER ON PD THERAPY BECAUSE HE HAS REGAINED HIS KIDNEY FUNCTION. PER NURSE, HP DID NOT REPORT TO ANY ISSUES WITH THERAPY OR PD PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR