BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1822910 · Received September 1, 2010

    Report

    Report Number
    1423500-2010-03066
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 8, 2010
    Report Date
    August 8, 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). THE SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE FOR THIS ISSUE IS CURRENTLY BEING INVESTIGATED THROUGH CAPA NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LOW DRAIN VOLUME WITH A REPORT OF AIR IN THE LINE WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. NO EVALUATION WILL BE PERFORMED. PRODUCT SURVEILLANCE FOLLOWED UP WITH THE PATIENT'S NURSE REGARDING THE ALARM. THE NURSE STATED THE PATIENT HAD NOT REPORTED THE INCIDENT TO HER, BUT THAT HE HAS HAD NO INJURIES OR ILLNESSES. THE PATIENT CONTINUES TO USE THE HOMECHOICE FOR PD THERAPY TO DATE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A LOW DRAIN VOLUME ALARM ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. DURING TROUBLESHOOTING THE HOME PATIENT (HP) REPORTED AIR IN THE PATIENT LINE AND REQUESTED TO BYPASS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT IF THERE WAS AIR IN THE LINE HE COULD NOT BYPASS TO FILL. TSR SUGGESTED TO BEGIN AGAIN WITH NEW SUPPLIES AND TO CALL BACK WITH ANY QUESTIONS. HP WILL START OVER WITH NEW SUPPLIES. 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 53 YR