BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 3173750 · Received June 17, 2013

    Report

    Report Number
    1416980-2013-15622
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS S12I18033 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION OF THE COMPANION SAMPLE WAS PERFORMED WITH NO ISSUES NOTED. A SIMULATED THERAPY WAS RUN USING THE RETURNED SAMPLE AND NO ALARMS OR ISSUES WERE FOUND. AS A RESULT, THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 3 INVOLVED IN THIS EVENT. THIS IS A REPORT OF A PATIENT LINE THAT CAME LOOSE WHILE THE PATIENT WAS PERFORMING PERITONEAL DIALYSIS THERAPY. THE CAUSE OF THE LOOSE CONNECTION WAS UNKNOWN. THREE CASSETTES WERE REPORTED TO HAVE THE SAME PROBLEM. THE PATIENT REMAINED WELL AND WAS GIVEN A LOADING DOSE OF ANTIBIOTICS AS A PRECAUTION FOR THE ACCIDENTAL DISCONNECTION. FURTHER TREATMENT WAS NOT REQUIRED. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273867 HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE S12I18033

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR