BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1880178 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04790
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 28, 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). THIS COMPLAINT FOR THE SYSTEM ERROR (AIR IN LINE) 2240 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    DURING A FOLLOW UP PHONE CALL BY PRODUCT SURVEILLANCE TO THE HOME PATIENT (HP), IT WAS REVEALED THAT THE HP DID NOT REMEMBER HAVING THIS ALARM. THE HP STATED THAT HE HAD NOT HAD ANY ISSUES WITH HIS SUPPLIES. THE HP DID NOT HAVE A SAMPLE AND DID NOT KNOW WHAT THE LOT NUMBER WAS.

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(6) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 THAT APPEARED WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. (B)(6) EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET, AND HAD THE PATIENT CYCLE POWER TO CLEAR THE ERROR. (B)(6) THEN ADVISED THE PATIENT TO DISCONNECT AND START OVER WITH NEW SUPPLIES. (B)(6) ALSO SUGGESTED THAT THE PATIENT CONTACT THEIR DIALYSIS NURSE REGARDING THE ERROR. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR