BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1984583 · Received February 11, 2011

    Report

    Report Number
    1423500-2011-01774
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    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 INVESTIGATION IS IN PROGRESS THROUGH (RENQ-CAPA-(B)(4)).

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LOW DRAIN VOLUME ALARM WAS NOT CONFIRMED DUE TO UNAVAILABLE SAMPLE. A SAMPLE EVALUATION WAS NOT PERFORMED DUE TO UNAVAILABLE SAMPLE. A BATCH REVIEW WAS NOT PERFORMED DUE TO UNKNOWN LOT NUMBER. A ROOT CAUSE WAS NOT IDENTIFIED DUE TO INSUFFICIENT INFORMATION. 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.

    Description of Event or Problem · 1

    A NURSE CONTACTED (B)(4) REGARDING ASSISTANCE WITH A LOW DRAIN VOLUME ALARM WHILE USING THE HOMECHOICE (HC) DURING DRAIN 1. (B)(4) HAD THE NURSE CLOSE/OPEN THE TRANSFER SET AND CHECK THE LINES FOR KINKS AND FIBRIN. THE NURSE STATED THERE WERE AIR BUBBLES IN THE PATIENT LINE. (B)(4) ADVISED THE NURSE THEY WOULD NEED TO END THERAPY AND START OVER WITH NEW SUPPLIES. (B)(4) THEN ASSISTED THE NURSE IN ENDING THERAPY. THE NURSE STATED THE PATIENT DID NOT WANT TO START OVER WITH NEW SUPPLIES. THE PATIENT ELECTED TO SKIP THERAPY FOR THE NIGHT AND START OVER TOMORROW. (B)(4) ADVISED THE NURSE TO NOTIFY THE PATIENT'S DIALYSIS NURSE IF HE DID NOT PERFORM THERAPY. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)