BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2872078 · Received December 13, 2012

    Report

    Report Number
    1416980-2012-07218
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 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). THIS COMPLAINT FOR A REPORT OF USE ERROR - FAILED TO FOLLOW THERAPY STEPS WAS CONFIRMED, BASED ON THE CUSTOMER REPORT. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED SINCE IT IS UNCERTAIN WHY THE PATIENT FAILED TO FOLLOW THERAPY STEPS. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE PREVENTION OF 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING A LOW UF ALARM WHICH OCCURRED ON THE HOMECHOICE (HC) DURING DRAIN 6 OF 6. THE CARE GIVER (CG) ALSO STATED THAT THE SOLUTION MUST HAVE LEAKED BECAUSE THE HP, THE BED, AND THE FLOOR WAS WET. THE CG STATED THAT THE HOME PATIENT (HP) WAS CONNECTED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED IF THE SOLUTION HAD BEEN CLEANED UP. THE CG STATED THAT IT HAD. THE TSR ASKED THE CG IF THE HP DISCONNECTED DURING THERAPY. THE HP HAD DISCONNECTED. THE TSR ASKED IF THE HP HAD USED ASEPTIC TECHNIQUE AND HAD USED A MINICAP AND A FLEXI CAP. THE CG STATED YES. THE TSR ASKED THE CG WHAT PHASE THE HC WAS IN. THE CG STATED THAT THE HC HAD TO IN DWELL WHEN THE HP DISCONNECTED. THE TSR EXPLAINED THAT THE HP COULD DISCONNECT ANYTIME DURING THERAPY. THE TSR ASKED THE CG IF SOLUTION CAME OUT OF THE TRANSFER SET WHEN THE HP DISCONNECTED. THE CG STATED THAT THE SOLUTION HAD COME OUT OF THE PATIENT LINE WHEN THE HP HAD DISCONNECTED. THE CG STATED THAT THE HP DID NOT USE A FLEXI CAP WHEN SHE DISCONNECTED. THE TSR EXPLAINED THAT THE HP SHOULD ALWAYS USE A FLEXI CAP IF SHE DISCONNECTS DURING THERAPY. THE TSR HAD THE CG CLOSE THE CLAMPS, DISCONNECT THE HP, AND CYCLE THE POWER. THE TSR ASSISTED WITH ENDING THERAPY AND GETTING THE SET OUT. THE TSR RECOMMENDED THE HP CONTACT HER NURSE AFTER THE CALL CONCLUDED ABOUT DISCONNECTING DURING THERAPY AND HOW SHE SHOULD COMPLETE THERAPY. 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 STATED THAT THE PATIENT HAD NOT CONTACTED HER ABOUT THIS EVENT. SHE STATED THAT SHE WOULD FOLLOW UP WITH THE PATIENT, BUT AS FAR AS SHE KNEW, THE PATIENT'S THERAPY HAD BEEN GOING WELL SINCE. 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