BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1900344 · Received November 16, 2010

    Report

    Report Number
    1423500-2010-05810
    Event Type
    Malfunction
    Date Received
    November 16, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/ USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WIL NOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT, FOR A CHECK PATIENT LINE ALARM, WAS NOT CONFIRMED. THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE CAUSE IS UNDETERMINED. SINCE THE LOT NUMBER IS UNKNOWN A BATCH REVIEW COULD NOT BE PERFORMED. USE ERROR WAS REPORTED; THE HOME PATIENT DISCONNECTED HIMSELF DURING THERAPY WITHOUT FOLLOWING PROPER PROCEDURES. CURRENT LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE FOR THE USE ERROR IDENTIFIED IN THIS REPORT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A CHECK PATIENT LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 2. DURING TROUBLESHOOTING, THE CAREGIVER (CG) REALIZED THAT THE HOME PATIENT (HP) HAD ALREADY DISCONNECTED AND PUT THE PATIENT LINE ON THE FLOOR. THE CG STATED SHE COULD END THERAPY. PRODUCT SURVEILLANCE CONTACTED THE NURSE ON (B)(6) 2010. ACCORDING TO THE NURSE THE PATIENT'S CG CALLED IMMEDIATELY AFTER THIS EVENT AND THEY GAVE THE HP ANTIBIOTICS PROPHYLACTICALLY. THE NURSE STATED THAT THE PATIENT HAS RESUMED THERAPY WITHOUT ANY INFECTION. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR