BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1853027 · Received October 5, 2010

    Report

    Report Number
    1423500-2010-04036
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 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). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) DURING INITIAL DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE DUE TO THE PATIENT BEGINNING THERAPY WITHOUT BEING CONNECTED. THE PATIENT THEN CONNECTED DURING INITIAL DRAIN. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: ON (B)(6) 2010, PRODUCT SURVEILLANCE SPOKE WITH THE HOME PATIENT 'S (HP) PERITONEAL DIALYSIS (PD) NURSE WHO REPORTED THE HP HAD BEEN RETRAINED ON ASEPTIC TECHNIQUE AND THAT HE HAD HAD NOT BEEN SWITCHED TO HEMODIALYSIS AS ORIGINALLY REPORTED. THE NURSE INDICATED THE PATIENT HAS REMAINED ON PD THERAPY AND HAS BEEN ABLE TO CONTINUE WITH PD THERAPY OKAY.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A SYSTEM ERROR 2240 (AIR IN SET) DURING INITIAL DRAIN ON THE HOMECHOICE (HC). THE HOME PATIENT (HP) REPORTED HAD PRESSED GO AND STARTED INITIAL DRAIN WITHOUT BEING CONNECTED; HP THEN CONNECTED HIMSELF TO MACHINE. THE HP WAS IN HOSPITAL AT THE TIME OF THIS ALARM. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD HP CLOSE ALL CLAMPS AND CYCLE POWER OFF/ON AND ADVISED HP TO START OVER WITH NEW SUPPLIES AND LET NURSE KNOW OF AIR DETECT ALARM. ON (B)(6) 2010 DURING FOLLOW UP WITH THE PERITONEAL DIALYSIS NURSE IT WAS REPORTED THAT THE HP PD THERAPIES WERE WITHDRAWN AND THE PATIENT WAS SWITCHED TO HEMODIALYSIS. THE NURSE DECLINED TO PROVIDE FURTHER INFORMATION BECAUSE THE PATIENT WAS PLACED IN A LONG TERM FACILITY.

    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 74 YR