BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2134055 · Received June 20, 2011

    Report

    Report Number
    1423500-2011-07859
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 27, 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). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, A BATCH REVIEW AND SAMPLE EVALUATION WILL NOT BE CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR A USER ERROR. THE REPORTED ISSUE WAS NOT CONFIRMED. HOWEVER, PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USE ERROR. LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    WHILE REPORTING A CHECK SUPPLY LINE ALARM DURING PRIME TO BAXTER'S TECHNICAL SERVICE CENTER, THE CUSTOMER STATED THAT WHILE THE HOMECHOICE WAS IN PRIME, THE CAREGIVER (CG) DISCONNECTED THEN RECONNECTED A BAG. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO START OVER WITH ALL NEW SUPPLIES. THE TSR ASSISTED THE CG WITH REMOVAL OF THE CASSETTE AND THE HC WAS IN THERAPY. THE TSR WALKED THE CG THROUGH ENDING THERAPY PROCEDURE AND ADVISED THE CG TO NOTIFY THE NURSE OF THIS EVENT. BAXTER PRODUCT SURVEILLANCE SPOKE WITH THE CG ON (B)(6) 2011. THE CG STATED THAT THE PATIENT RAN SHORT OF SOLUTION SO SHE WAS TOLD TO RESET THE CYCLER UP WITH NEW SUPPLIES AND JUST DO THE FIRST 2 CYCLES. THE CG SAID THAT PATIENT'S THERAPY HAS SINCE BEEN CHANGED FROM 2 BAGS TO 3 BAGS. THE CG DID NOT PROVIDE ANY ADDITIONAL INFORMATION REGARDING DISCONNECTING THE SUPPLY BAG AND RECONNECTING WHEN ASKED. THE CG SAID THAT EVERYTHING HAS BEEN RESOLVED AND THE HP IS CONTINUING THERAPY WITH NO FURTHER ISSUES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 65 YR HOMECHOICE