BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2013974 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-03029
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 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 A LEAK WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. FROM THE INFORMATION PRESENT IN THE COMPLAINT, THE ROOT CAUSE WAS DETERMINED TO BE A LOOSE CONNECTION BETWEEN THE PATIENT LINE AND THE TRANSFER SET DUE TO USER ERROR. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED.THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) REGARDING ASSISTANCE WITH THE HOMECHOICE (HC) UNIT DURING USE. THE HOME PATIENT (HP) WAS NOT CONNECTED. PER THE INITIAL REPORT, THE HP STATED THAT SHE NEEDS TO RESTART THE SETUP WITH NEW SUPPLIES DUE TO A DEFECTIVE CASSETTE. (B)(4) ASSISTED THE HP TO CYCLE POWER TO RESTART THE SETUP WITH ALL NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. A FOLLOW UP WAS DONE VIA PHONE. THE HP STATED THAT THE PATIENT LINE DIDN'T CONNECT PROPERLY TO HER TRANSFER SET; THERE WAS A LOOSE CONNECTION WHICH CAUSED SOLUTION TO FLOW OUT FROM THE PATIENT LINE. HP STATED THAT SHE DIDN'T OPEN HER TRANSFER SET FOR CONNECTION YET AT THAT TIME, SO THERE WAS NO INJURY AS A RESULT. HP STATED IT SEEMED STRANGE THAT THERE WAS A LOOSE CONNECTION AND SHE JUST ENDED UP STOPPING AND ENDING THE THERAPY AND THEN JUST NOTIFIED HER NURSE. HP STATED THAT SHE MAY NOT HAVE TWISTED THE PATIENT LINE TO THE TRANSFER SET ENOUGH TO MAKE A SECURE CONNECTION, BUT SHE WASN'T SURE. HP SAID IT OCCURRED ONLY ONCE, AND DISCARDED THE SUPPLIES AFTER THERAPY. THE LOT INFORMATION WAS UNKNOWN. HP WAS SUCCESSFULLY CONTINUING THERAPY WITH NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR HOMECHOICE