BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1981965 · Received February 8, 2011

    Report

    Report Number
    1423500-2011-01662
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 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 SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF AN UNSPECIFIED ALARM. THIS COMPLAINT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. THE PATIENT STATED THEY STARTED OVER WITH NEW SUPPLIES AND THEY DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE THAT WAS IN USE. THERE WAS NOT ENOUGH DATA WITHIN THE COMPLAINT INFORMATION TO IDENTIFY ROOT CAUSE; THEREFORE THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER THAT HE RECEIVED ALARM MESSAGE ON THE HOMECHOICE (HC) CYCLER. THE HOME PATIENT (HP) SAID THAT IT WAS A FAULTY CASSETTE. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT (HP) REGARDING THE REPORTED EVENT. THE HP COULD NOT RECALL THE DATE OF THE ALARM OCCURRED OR THE ALARM. THE HP STATED THEY STARTED OVER WITH NEW SUPPLIES. THE HP STATED THEY DID NOT NOTICE ANY VISIBLE DAMAGE OR ABNORMALITIES WITH THE CASSETTE THAT WAS IN USE. THE HP STATED THEY DISCARDED THE SAMPLE, AND PROVIDED THE LOT NUMBER. THE HP STATED THAT THEY WERE ABLE RESUME THERAPY SUCCESSFULLY WITH NEW SUPPLIES. THE PATIENT WAS INVOLVED, BUT 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 H10J06021

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR HOME CHOICE CYCLER