BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1981804 · Received February 8, 2011

    Report

    Report Number
    1423500-2011-01650
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 15, 2011
    Report Date
    January 15, 2011
    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 IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S QUALITY REVIEW.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT FOR A CONNECTION ISSUE WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN; THEREFORE, A BATCH REVIEW WAS NOT PERFORMED. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS DUE TO A SUPPLY BAG FALLING AND DISCONNECTING. THE CAREGIVER STATED THE BAG FELL BECAUSE SHE SETS UP THE THERAPY WITH THREE BAGS AND THE AREA NEXT TO THE CYCLER WAS TOO SHORT. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. SIMILAR REPORTS HAVE BEEN RECEIVED 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 CAREGIVER (CG) CONTACTED (B)(4) REGARDING A BAG THAT FELL AND DISCONNECTED ON THE HOME CHOICE (HC) DURING DRAIN 4 OF 5. THE DRAIN VOLUME (DV) = 1359 ML. (B)(4) ASSISTED THE CG TO END THERAPY AND ADVISED TO CONTACT THE PERITONEAL DIALYSIS (PD) NURSE TO INFORM OF THE INCIDENT. ON (B)(6) 2011 PRODUCT SURVEILLANCE SPOKE WITH THE CG WHO STATED SHE DID NOT NOTICE ANYTHING UNUSUAL WITH THE SUPPLIES. THE CG STATED THE BAG FELL BECAUSE OF HER OWN ERROR AS SHE SETS UP THE THERAPY WITH THREE BAGS AND THE AREA NEXT TO THE CYCLER TO PUT BAGS WAS TOO SHORT. THE CG STATED THE BAG ON THE END WAS TOO CLOSE TO THE EDGE OF THE TABLE EXTENSION AND THIS PARTICULAR NIGHT DURING DRAIN IT FELL OFF. THE CG CONFIRMED THIS WAS AN ISOLATED INCIDENT AND REPORTED NO ADVERSE EVENT RESULTING FROM THIS REPORT.

    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 69 YR HOMECHOICE APD SYSTEM/REF (B)(4)