BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2123591 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07611
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 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. 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. THE COMPLAINT 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

    AFTER REPORTING A CHECK HEATER LINE ALARM TO BAXTER?S TECHNICAL SERVICE CENTER THE HOME PATIENT (HP) STATED THAT HE HAD DISCONNECTED HIMSELF AND REPLACED THE HEATER BAG. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP THAT BOTH LINES AND BAGS SHOULD BE REPLACED. THE TSR ASSISTED THE HP WITH END OF THERAPY EARLY PROCEDURE AND REMOVING THE CASSETTE. PRODUCT SURVEILLANCE CONTACTED THE HP ON (B)(6) 2011. THE HP DOES NOT REMEMBER IF HE HAD DISCONNECTED AND CHANGED THE HEATER BAG BEFORE OR AFTER THE HOMECHOICE HAD ALARMED. THE HP DID NOT REMEMBER IF HE HAD RECONNECTED OR NOT. THE HP VERIFIED THAT THERE WERE NO LOOSE CONNECTIONS, OR DISCONNECTIONS. THE HP STATED THAT HE IS DOING FINE AND CONTINUING THERAPY WITHOUT ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP?S DIALYSIS PRODUCTS. NO FURTHER INFORMATION WAS PROVIDED.

    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 68 YR HOMECHOICE