BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2880174 · Received December 19, 2012

    Report

    Report Number
    1416980-2012-07742
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    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). THE PROBLEM OF USE ERROR, RE-USE OF SINGLE USE PRODUCT WAS CONFIRMED, BASED ON THE PATIENT'S REPORT. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED AS IT IS UNCERTAIN WHY THE PATIENT RE-USED SINGLE USE PRODUCT. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE PREVENTION OF THE USE ERROR IN THIS COMPLAINT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING AN ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED HE BYPASSED TO FILL AND HAD DONE HIS OWN TEST FILL. THE HP STATED THAT HE THEN TURNED THE HC OFF AND HAD STARTED THERAPY ALL OVER FROM THE BEGINNING WITH THE SAME SUPPLIES AND HAD DRAINED OUT THE TEST FILL BY USING THE INITIAL DRAIN. THE HP STATED THAT HE HAD DONE A MANUAL DRAIN WITH BAXTER BEFORE AND HE THOUGHT THAT THIS IS WHAT THE INSTRUCTIONS WERE. THE HP STATED THAT HE HAS BEEN GETTING A LOT OF LOW DRAIN VOLUME (LDV) ALARMS LATELY AND HE HAD BEEN DOING HIS OWN BYPASSING AND TEST FILLS TO BYPASS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO CONTACT HIS PERITONEAL DIALYSIS REGISTERED NURSE AND INFORM THEM OF HIS LDV ISSUES. THE TSR ADVISED THE HP TO CALL BAXTER WHENEVER HE GETS A LDV ALARM SO THAT PROPER TROUBLE SHOOTING COULD TAKE PLACE. THE TSR INFORMED THE HP THAT THE WAY THEY WERE DOING A TEST FILL WAS NOT ACCORDING TO PROCEDURES. THE HC WAS OPERATIONAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE ON (B)(4) 2012. SHE DID NOT KNOW ABOUT THE REPORTED ISSUES AND WOULD FOLLOW UP WITH THE PATIENT. THE PATIENT'S THERAPY HAS BEEN GOING WELL AND SHE HAD SEEN THE PATIENT THAT MORNING. THERE WERE NO ADVERSE EFFECTS REPORTED IN RELATION TO THIS EVENT.

    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 66 YR HOMECHOICE