BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2063556 · Received April 19, 2011

    Report

    Report Number
    1423500-2011-04732
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 26, 2011
    Report Date
    March 26, 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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR USE ERROR WAS NOT CONFIRMED. THE ROOT CAUSE OF THE COMPLAINT IS USE ERROR. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE 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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE HOME PATIENT (HP) CONTACTED BAXTER FOR ASSISTANCE IN RE-PRIMING THE PATIENT LINE. THE HP REPORTED THAT THEY HAD PULLED THE CAP OFF OF THE PATIENT LINE WHILE THE LINE WAS PRIMING. THE HP STATED THAT THEY WOULD START THE PRIME AGAIN WITH NEW SUPPLIES. ON (B)(6) 2011, BAXTER CONTACTED THE PERITONEAL DIALYSIS NURSE(PDRN) REGARDING THE INCIDENT OF USER ERROR ON (B)(6) 2011. THE PDRN STATED THAT THE HP HAD NOT CALLED THE CLINIC TO REPORT THE INCIDENT, BUT THAT THE HP HAD REQUIRED NO INTERVENTION DUE TO THE OCCURRENCE.

    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 31 YR LO CAL (PD4) ULTRABAG| HOME CHOICE CYCLER| LO CAL (PD4) AMBUFLEX