BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1801926 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02548
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. A LABELING REVIEW WAS PERFORMED AND FOUND TO BE ADEQUATE FOR THE USE ERROR IDENTIFIED IN THIS COMPLAINT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE BATTERY NEEDS TO BE REPLACED. NO PT INVOLVEMENT OR ADVERSE CONSEQUENCES ARE REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING SYSTEM ERROR (SE) 2240, WHICH OCCURRED ON THE HOMECHOICE DURING DRAIN 2/4. THE HOME PATIENT (HP) STATED SHE DISCONNECTED HERSELF IN DWELL AND WHEN SHE RETURNED, THE DRAIN CYCLE HAD STARTED AND SHE RECONNECTED. THE SE 2240 THEN OCCURRED. THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE HP. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE SPOKE TO THE HP REGARDING THE INCIDENT. PER THE HP, SHE DISCONNECTED AND RECONNECTED DURING DWELL. A COUPLE OF MINUTES AFTER SHE RECONNECTED, THE SE 2240 OCCURRED. THE HP WAS TREATED WITH ANTIBIOTICS AS A PROPHYLACTIC MEASURE. THE HP IS CONTINUING THERAPY ON THE HC WITHOUT DIFFICULTY.

    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 58 YR