BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2042536 · Received April 6, 2011

    Report

    Report Number
    1423500-2011-04151
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 12, 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 REPORT OF 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. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USER ERROR/ MIS-USE. 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING A CALL TO BAXTER'S TECHNICAL SERVICE CENTER A HOME PATIENT (HP) REPORTED THAT HE HAD DISCONNECTED THE HEATER BAG. THE PATIENT DID THIS AFTER RECEIVING A CHECK HEATER LINE ALARM ON THE HOMECHOICE (HC) DURING FILL 1. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE SUPPLIES WERE COMPROMISED AND THE HP WOULD NEED TO START OVER WITH NEW SUPPLIES. THE HP STATED THAT THEY WERE OUT OF TOWN AND THEY ONLY HAD ONE NIGHT WORTH OF BAGS LEFT. THE HP STATED THAT THEY WERE JUST GOING TO CHANGE OUT THE BAG. THE TSR EXPLAINED THAT THE HP WAS PUTTING THEM AT A HUGE RISK OF INFECTION. THE HP STATED THAT THEY WOULD TAKE THEIR CHANCES. THE TSR WALKED THE HP THROUGH ENDING THERAPY PROCEDURE BUT THE HP MAY RE-USE THE BAGS. THE TSR WOULD SEND THE SUPERVISOR A MESSAGE FOR POSSIBLE FOLLOW UP CALL TO CLINIC. THE HP ENDED THERAPY AND WOULD START OVER. PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE (PD RN) ON (B)(6) 2011 REGARDING THE REPORTED PROBLEM. PER THE PD RN, THE HP FOLLOWED UP WITH THE NURSE REGARDING THE ALARM AND THE PROBLEM WAS RESOLVED. THE PD RN ALSO STATED THAT THE HP NEVER HAD PERITONITIS. THE HP WAS CONTINUING THERAPY WITHOUT ANY OTHER COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED. THIS REPORT ADDRESSES THE USE ERROR OF THE CASSETTE.

    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 67 YR HOMECHOICE