BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1873134 · Received October 18, 2010

    Report

    Report Number
    1423500-2010-04571
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 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). AN ENGINEERING QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A SYSTEM ERROR (SE) 2240 ALARM. THE REPORT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THE SE 2240 WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER INCOMPLETE PRIMING. THE PATIENT STATED THAT THE PATIENT LINE WAS NOT PRIMED WHEN SHE CONNECTED AND STARTED THE INITIAL DRAIN. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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). THE SAMPLE WAS DISCARDED. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REGARDING A SYSTEM ERROR (SE) 2240 ALARM THAT OCCURRED ON THE HOMECHOICE (HC) UNIT DURING INITIAL DRAIN. THE HP STATED THAT THE PATIENT LINE WAS NOT PRIMED WHEN SHE CONNECTED AND STARTED THE INITIAL DRAIN. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP TO CYCLE POWER TO CLEAR ALARM. THE TSR THEN ADVISED THE HP TO DISCONNECT USING ASEPTIC TECHNIQUE AND REMOVE CASSETTE. THE HP CONFIRMED SHE WOULD NOTIFY HER PERITONEAL DIALYSIS NURSE AND START OVER WITH NEW SUPPLIES.. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL WITH THE HP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    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 61 YR