BEUDAMED
    FDA Adverse Event Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1862011 · Received October 8, 2010

    Report

    Report Number
    1423500-2010-04168
    Date Received
    October 8, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 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). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LOW DRAIN VOLUME ALARM (LDVA) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. 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 THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT A LOW DRAIN VOLUME (LDV) ALARM ON THE HOMECHOICE (HC) MACHINE DURING DRAIN 1 OF 4. THE HOMEPATIENT (HP) STATED THAT THERE WAS AIR IN PATIENT LINE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED IN ENDING THERAPY AND SUGGESTED CALLING THE NURSE. ON (B)(6) 2010 PRODUCT SURVEILLANCE CONTACTED THE NURSE REGARDING THE ALARM. THE NURSE STATED THAT THE PATIENT DISCARDED THE SUPPLIES AND STARTED OVER WITH NEW ONES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A KYPHOPLASTY PROCEDURE. DURING THE PROCEDURE, THERE WAS A CEMENT LEAKAGE. NO ADDITIONAL INFORMATION 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1