BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3 PRONG

    MDR report key: 1935397 · Received December 22, 2010

    Report

    Report Number
    1423500-2010-07136
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 2, 2010
    Report Date
    December 2, 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). A QUALITY REVIEW WAS COMPLETED FOR THIS REPORT OF A CHECK HEATER LINE ALARM. THIS REPORT WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE INCIDENT WAS NOT DETERMINED. DURING FOLLOW UP WITH THE CUSTOMER, A USE ERROR WAS IDENTIFIED. THE PATIENT STATED THAT THE PATIENT LINE CLAMP WAS CLOSED. 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 REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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 WILL NOT BE CONDUCTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING THE HOME CHOICE (HC) ALARM SITUATION CHECK HEATER LINE ALARM THAT OCCURRED DURING FILL 1. THE HOME PATIENT (HP) STATED THAT THE PATIENT LINE WAS FULL OF AIR. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THIS AND ADVISED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR STRESSED THE IMPORTANCE OF MAKING SURE THE PATIENT LINE IS FULLY PRIMED BEFORE CONNECTING HIMSELF. THE TSR THEN WALKED THE HP THROUGH THE ENDING THERAPY EARLY PROCEDURE AND THE HP STARTED OVER WITH NEW SUPPLIES. BAXTER PRODUCT SURVEILLANCE SPOKE WITH THE HP ON (B)(6) 2010. PER THE HP, HE WAS ABLE TO START OVER WITH NEW SUPPLIES AND PRIMING WAS COMPLETED. THE HP STATED THAT HE FOUND HIS MISTAKE AND THAT DURING PRIMING HE HAD THE PATIENT LINE CLOSED. IT WAS RECOMMENDED THE HP CALL AT ANYTIME IF HE HAS ANY QUESTIONS OR NEEDS ASSISTANCE DURING PRIME AND THAT THE INFORMATION IS ALSO IN HIS AT HOME GUIDE. THE HP STATED HE WAS DOING GOOD WITH THE PRIMING. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR HOMECHOICE APD CYCLER