BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3043075 · Received April 9, 2013

    Report

    Report Number
    1416980-2013-08807
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 17, 2013
    Report Date
    March 17, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. AS THE CASSETTE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER?S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR (SE) 2240 ALARM (AIR IN TUBING), WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DRAIN 3 OF 5. THE HP SAW AIR THAT APPEARED TO BE COMING FROM THE TRANSFER SET. THE HP STATED THAT HE HAS AN APPOINTMENT FOR THE TRANSFER SET TO BE REPLACED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE HOME PATIENT WAS CONTACTED AND HE SAID HE WENT TO SEE HIS NURSE THAT DAY AND THEY WERE NOT ABLE TO DETERMINE WHERE THE AIR CAME FROM. HE SAID THERE WAS NO LEAK ON HIS TRANSFER SET OR ANYWHERE ELSE. HE SAID THAT HIS NURSE CHANGED HIS TRANSFER SET THAT DAY AND SINCE THEN HE HAS BEEN COMPLETING THERAPY SUCCESSFULLY. HIS NURSE HAD HIM TAKE ANTIBIOTICS AS A PRECAUTIONARY MEASURE. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147345 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOME CHOICE