BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2070907 · Received April 27, 2011

    Report

    Report Number
    1423500-2011-05088
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    November 9, 2010
    Report Date
    November 9, 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). SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS NOT CONFIRMED. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER IN THIS COMPLAINT; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. BASED ON THE INFORMATION GATHERED DURING BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS DUE TO USER ERROR. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR A 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

    DURING TROUBLESHOOTING FOR REFERENCED MASTER COMPLAINT, THE HOME PATIENT (HP) STATED HE HAD DISCONNECTED THE SUPPLY BAG TO SEE IF ANYTHING WAS GOING THROUGH THE LINE. THE HP THEN STATED THAT HE RECONNECTED THE SUPPLY LINE TO THE BAG. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THE TSR ADVISED THE HP HE SHOULD NEVER DISCONNECT THE LINES DURING THE SETUP OR THERAPY AND THEN RECONNECT. THE TSR EXPLAINED TO THE HP THAT ONCE THE LINES ARE DISCONNECTED THE SETUP IS NO LONGER STERILE. THE TSR ASSISTED THE HP TO END THE SETUP. ON (B)(6) 2010, PRODUCT SURVEILLANCE SPOKE WITH THE HP WHO STATED THAT AFTER STARTING OVER WITH NEW SUPPLIES NO FURTHER ISSUES OCCURRED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION RESULTING FROM THIS INCIDENT.

    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 PRO