BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2033010 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03821
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 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). THIS COMPLAINT IS FOR A REPORT OF A CHECK LINES AND BAGS ALARM. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE ALARM IS IMPROPER SETUP OF THE SUPPLY BAG CONNECTION. LABELING WAS REVIEWED FOR POSSIBLE USE ERRORS AND THERE WERE NO ISSUES AND NO LABEL DEFICIENCY. 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 (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    A CARE GIVER (CG) CONTACTED (B)(4) REGARDING A CHECK LINES AND BAGS/REFILLING THE HEATER ALARM THAT OCCURRED ON THE HOME CHOICE (HC) UNIT DURING FILL. THE CG STATES THAT WHEN HE SETUP THE HC TONIGHT HE PUT THE FINAL BAG ON THE WHITE LINE AND THE SUPPLY BAG ON THE FINAL LINE, HE GOT THE ALARM AND THEN DISCONNECTED THE FINAL BAG FROM THE WHITE LINE AND CONNECTED THE SUPPLY BAG TO IT. THE TECHNICAL SERVICE REPRESENTATIVE EXPLAINED THAT BAGS CANNOT BE CONNECTED AND RECONNECTED DURING THERAPY AND THAT CURRENT THERAPY SHOULD BE ENDED. THE TSR ASSIST WITH ENDING THERAPY AND THE CG STATES HE WILL ASSIST HOME PATIENT (HP) WITH MANUAL TO MAKE UP FOR THE MISSED CYCLES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. A FOLLOW UP WAS DONE VIA PHONE. THE NURSE SAID SHE HAD NOT BEEN NOTIFIED OF THE ISSUE. THE NURSE SAID AS FAR AS SHE KNEW THE HP HAD NOT HAD ANY COMPLICATIONS, INJURY OR 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 63 YR HOMECHOICE