BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1890379 · Received November 3, 2010

    Report

    Report Number
    1423500-2010-05224
    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). 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.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING DWELL 4 OF 5. THE SUPPLY BAG REPORTEDLY FELL AND DISCONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO CLEAR THE ALARM. THE HP WOULD COMPLETE THERAPY USING MANUAL SUPPLIES. DURING A FOLLOW UP WITH THE HP REGARDING THE BAG FALLING AND DISCONNECTING, THE HP EXPLAINED THAT THE I.V. POLE THAT SHE HANGS THE SUPPLY BAG ON ACCIDENTALLY FELL, CAUSING THE BAG TO BE DISCONNECTED FROM THE CASSETTE TUBING. THE HP THEN REVEALED THAT THE BASE OF THE POLE HAS GOTTEN RUSTY, AND THAT MIGHT HAVE CAUSED THE POLE TO TIP OVER. THE HP ADDED THAT HER NURSE IS FINE WITH THE HP USING THE I.V. POLE, AND SHE HAD ALSO DISCUSSED THIS EVENT WITH THE NURSE. PER HP, HER NURSE WILL BE ARRANGING FOR A NEW I.V. POLE FOR HER. THE HP STATED THAT SHE HAD DISCARDED THE SUPPLIES AFTER THERAPY, AND DID NOT KNOW THE LOT NUMBERS. THE HP CONFIRMED THAT SHE DID NOT HAVE ANY INJURY OR HARM AS A RESULT OF THIS INCIDENT AND THERE WERE NO DEFECTS ON THE SUPPLIES. THE HP STATED THAT SHE HAS RESUMED THE THERAPY. 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 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR