BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1981375 · Received February 8, 2011

    Report

    Report Number
    1423500-2011-01634
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 14, 2011
    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 USED SAMPLE WAS NOT RETURNED TO BAXTER FOR EVALUATION; THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. A USE ERROR OCCURRED AFTER THE ALARM. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORT HAS BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR. THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION; THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING A CHECK SUPPLY LINE ALARM THAT OCCURRED ON THE HOME CHOICE (HC) DURING PRIME. THE HP STATED THAT HE CHANGED OUT THE CASSETTE AFTER GETTING THE ALARM BUT DID NOT CHANGE THE BAGS. GTS ADVISED THE HP TO START OVER WITH NEW BAGS AND A NEW CASSETTE BECAUSE THE SUPPLIES WERE NOW COMPROMISED. THE HP CONFIRMED TO START OVER WITH NEW SUPPLIES. ON (B)(4) 2011, PRODUCT SURVEILLANCE SPOKE WITH THE HP'S NURSE WHO CONFIRMED SHE WOULD REVIEW PROPER PROCEDURES WITH THE HP. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 68 YR HOMECHOICE APD SYSTEM/REF ((B)(4))