BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3051474 · Received April 10, 2013

    Report

    Report Number
    1416980-2013-08996
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CONNECTION ISSUE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING DWELL 5 OF 6. PER THE HOME PATIENT (HP) THE PATIENT LINE DISCONNECTED. PER THE HP THERE WERE NO ALARMS AND THE PATIENT LINE BECAME DISCONNECTED DURING THERAPY. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THEM TO END THERAPY AS REQUESTED AND THE TSR EXPLAINED THEY COULD NOT RESTART THERAPY WHERE THEY LEFT OFF. THE HP WOULD FOLLOW UP WITH A MANUAL SUPPLIES AND THE HP SAID THE REGISTERED NURSE (RN) WAS AWARE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT ON (B)(4) 2013 AND HE SAID THAT HE ROLLED OVER WHILE IN BED AND THAT WAS WHEN THE DISCONNECTION OCCURED. HE SAID HE THEN ALSO FELT HIS CROTCH REGION WAS WET FROM THE DISCONNECTION AND SOME OF THE SOLUTION HAVING LEAKED. HE QUICKLY CLOSED THE TRANSFER SET UP AND CAPPED IT AS WELL. HE THEN CONTACTED HIS NURSE AND FINISHED WITH MANUAL SUPPLIES. SINCE THEN HE HAS BEEN COMPLETING THERAPY SUCCESSFULLY. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149975 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HOMECHOICE