BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2101012 · Received May 24, 2011

    Report

    Report Number
    1423500-2011-06423
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    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 REPORT OF A USE ERROR WAS CONFIRMED; HOWEVER, A CAUSE AS TO WHY THE PATIENT DIDN'T FOLLOW PROPER STEPS COULD NOT BE DETERMINED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING OF A CHECK LINES & BAGS ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING PRIME, THE HOME PATIENT (HP) REVEALED THAT THEY CHANGED THE CASSETTE, BUT DID NOT CHANGE THE BAGS AS WELL. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED TO THE HP THAT THE SETUP ON THE HC MACHINE WAS COMPROMISED AND THEY COULD NOT USE THAT SETUP. THE TSR THEN ADVISED THE HP TO START OVER WITH ALL NEW SUPPLIES; NEW BAGS AND NEW CASSETTE. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE