BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3092636 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11273
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE SAMPLE HAS BEEN MADE. SHOULD THE SAMPLE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT) EXPERIENCED PERITONITIS DUE TO A LEAK IN THE CASSETTE LINE. IT WAS REPORTED THAT 15 DAYS PRIOR TO THE RECEIPT OF THIS ADDITIONAL INFORMATION, THE PT WAS HOSPITALIZED FOR 10 DAYS FOR PNEUMONIA. ONE DAY AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PT WAS DIAGNOSED WITH PERITONITIS. IT WAS REPORTED THAT ON UNSPECIFIED DATES PRIOR TO EXPERIENCING THE PERITONITIS, THE PT EXPERIENCED A LEAK (UNSPECIFIED NUMBER) IN THE CASSETTE LINE AND THAT ALTHOUGH THE LEAKS WERE FOUND DURING PRIME, THE CUSTOMER HAS USED THE CASSETTES USING ELECTRICAL TAPE TO STOP THE LEAKING. ON AN UNREPORTED DATE, THE PT RECEIVED UNSPECIFIED ANTIBIOTICS (DOSE FREQUENCY AND LOT NOT REPORTED) AS TREATMENT FOR THE PERITONITIS. ON AN UNREPORTED DATE THE PT RECEIVED RE-TRAINING IN PROPER ASEPTIC PROCEDURES. AT THE TIME OF THIS REPORT, THE PT WAS CURRENTLY RECOVERING FROM THE PERITONITIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER?S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 (AIR IN TUBING)/2367 ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING INITIAL DRAIN. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CAREGIVER (CG) POWER CYCLE THE MACHINE AND THE CG STATED THE PATIENT LINE HAD A SMALL HOLE IN IT. THE PATIENT WAS CONNECTED EITHER AT THE TIME OF THE ALARM OR OBSERVED AIR. THERE WAS PATIENT INVOLVEMENT BUT 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
    194843 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention HOME CHOICE