BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2083903 · Received May 11, 2011

    Report

    Report Number
    1423500-2011-05726
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    April 17, 2011
    Report Date
    April 17, 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 USER ERROR. THE HOMECHOICE WAS IN FILL 1 HOWEVER THE PATIENT WAS NOT CONNECTED. PATIENT SHOULD BE CONNECTED FOR THERAPY. COMPLAINT WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USE ERROR. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    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. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT HAVING STARTED THERAPY BEFORE CONNECTING TO THE HOMECHOICE (HC) MACHINE. THE HOME PATIENT (HP) STATED HE WAS PRIMING THE HC WHEN HE NOTICED THAT THE LINE WAS EMPTY. THE HP STATED THAT HE PRESSED GO AND WAS IN FILL 1, BUT WAS NOT CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO END THERAPY AND START OVER WITH NEW SUPPLIES. THE TSR THEN WALKED THE HP THROUGH ENDING THERAPY PROCEDURE. THE HC WAS OPERATIONAL. THE RESOLUTION TO THIS REPORTED CONDITION WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HP REGARDING THE REPORTED EVENT ON (B)(6) 2011. THE HP STATED THAT HE WAS TRYING TO REPRIME THE PATIENT LINE WHEN HE SAW THAT THE CYCLER MOVED ON TO FILL 1. THE HP DID NOT KNOW HOW EXACTLY THIS OCCURRED. HE STATED THAT HE CALLED HIS PERITONEAL DIALYSIS (PD) NURSE WHO WANTED HIM TO START OVER WITH NEW SUPPLIES, HOWEVER HE INSISTED THAT HE DID NOT BREAK STERILITY AND WANTED TO USE THE SAME SUPPLIES. THE HP STATED THAT HE DID USE THE SAME SUPPLIES FOR THERAPY. HE EXPLAINED THAT HE REPRIMED THE LINES AND PERFORMED THERAPY WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION 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 73 YR HOMECHOICE PRO