BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3926581 · Received July 10, 2014

    Report

    Report Number
    1416980-2014-22037
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - REUSE OF SINGLE-USE PRODUCT DURING THE PRIMING STAGE, WHERE THE HOME PATIENT STATED THAT HE CHANGED OUT THE CASSETTE BUT DID NOT CHANGE OUT THE SOLUTION BAGS. USE ERRORS AND PROPER USER INSTRUCTIONS ARE ADDRESSED IN THE HOMECHOICE AND HOMECHOICE PRO SYSTEMS PATIENT AT-HOME GUIDE. THE GUIDE INSTRUCTS THE USER NOT TO ATTEMPT TO REUSE ANY DISPOSABLE SUPPLIES. ADDITIONALLY, THE GUIDE WARNS THE USER THAT POSSIBLE CONTAMINATION OF THE FLUID OR FLUID PATHWAYS CAN RESULT IF DISPOSABLES ARE REUSED. THIS REVIEW FINDS THE LABELING ACCESSIBLE, ACCURATE, AND ADEQUATE FOR THE RELATED USE ERROR(S) IN THE COMPLAINT. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT (HP) REUSED SINGLE-USE SUPPLIES DURING PERITONEAL DIALYSIS (PD) THERAPY. DURING TROUBLESHOOTING FOR AN UNRELATED ISSUE, THE PATIENT CHANGED OUT THE CASSETTE RATHER THAN THE ENTIRE SET-UP. THE PATIENT WOULD COMPLETE THERAPY USING NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403408 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE