BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1902205 · Received November 18, 2010

    Report

    Report Number
    1423500-2010-05926
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 24, 2010
    Report Date
    October 24, 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 SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: A BATCH REVIEW WAS PERFORMED AND NO ISSUES WERE NOTED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) SYSTEM ERROR 2240. THIS ERROR OCCURRED DURING DWELL 3 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT (HP) TO CYCLE POWER. THE TSR ADVISED THE HP TO DISCONNECT AND THE HP STATED THAT SHE WOULD FINISH THERAPY USING MANUAL SUPPLIES. THE TSR ADVISED THE HP TO CALL THE NURSE IN THE MORNING. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE WAS CONTACTED BY THE PATIENT ON (B)(6) 2010. THE PATIENT STATED THE FOLLOWING: NOTHING WAS NOTICED WITH THE SUPPLIES AND THE SAMPLE WAS DISCARDED. THE BOX WAS EMPTY SO A COMPANION SAMPLE WAS NOT AVAILABLE AND THE LOT NUMBER WAS H10F26042. THE PATIENT HAD CONTACTED THE NURSE REGARDING THE EVENT AND THE NURSE DID NOT HAVE THE PATIENT USE ANTIBIOTICS. THE THERAPY WAS GOING FINE OTHERWISE.

    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 H10F26042

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR