BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2032783 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03789
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 5, 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 WAS NOT CONFIRMED. 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 USE ERROR. LABEL REVIEW WAS PERFORMED AND THE REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A CHECK HEATER LINE ALARM WHICH OCCURRED ON HOME CHOICE (HC) DURING USE DURING FILL 1. THE HOME PATIENT (HP) STATED THAT THE HC WAS ALARMING CHECK HEATER LINE SO SHE WENT AHEAD AND CHANGED THE HEATER BAG AND CONTINUED WITH THE SAME SET UP AND THEN CALLED BAXTER. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND THEN ASSISTED THE HP TO CYCLE POWER OFF AND ON, END THERAPY AND THEN EXPLAINED TO START OVER WITH NEW SUPPLIES. THE TSR EXPLAINED TO THE HP THAT ONCE THE SET UP IS CONTAMINATED IT CANNOT BE USED AGAIN. THE HP STATED OK. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE CUSTOMER CONTACTED PRODUCT SURVEILLANCE ON (B)(4) 2011. THE HOME PATIENT (HP) STATED THAT SHE WAS ABLE TO COMPLETE THERAPY WITH NEW SUPPLIES. THE HP STATED THAT SHE DID NOT NOTICE ANY DEFECT WITH THE ORIGINAL CASSETTE. THE HOME PATIENT (HP) DISCARDED THE ORIGINAL CASSETTE AND DID NOT HAVE A COMPANION AVAILABLE. THE HP DID NOT KNOW THE LOT NUMBER. THE HP STATED SHE WOULD CALL THE PERITONEAL DIALYSIS NURSE (RN) ABOUT DISCONNECTING AND RECONNECTING THE HEATER BAG DURING THERAPY. 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 HOMECHOICE