BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1914850 · Received December 4, 2010

    Report

    Report Number
    1423500-2010-06539
    Event Type
    Malfunction
    Date Received
    December 4, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 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. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE; HOWEVER BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE CAUSED WHEN THE PATIENT PULLED THE LINE OUT OF THE SUPPLY BAG, ALLOWING AIR TO BE SUCKED INTO THE DISPOSABLE. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT INFORMATION WAS UNKNOWN. 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 CAREGIVER CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DWELL 5 OF 6. THE CAREGIVER STATED THAT THE PATIENT HAD PULLED THE LINE OUT OF THE SUPPLY BAG. GTS HAD THE CAREGIVER CYCLE POWER TO CLEAR THE SYSTEM ERROR AND END THERAPY. (B)(4) THEN HAD THE CAREGIVER ASEPTICALLY DISCONNECT THE PATIENT AND REMOVE THE CASSETTE. THE CAREGIVER ELECTED TO DISCARD THE SUPPLIES AND NOTIFY THE PATIENT'S DIALYSIS NURSE. THE LOT INFORMATION WAS UNATTAINABLE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S DIALYSIS NURSE. SHE STATED THAT THE PATIENT DID NOT DEVELOP ANY ADVERSE EVENTS AND WAS ABLE TO CONTINUE THERAPY WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR