BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 3670816 · Received March 10, 2014

    Report

    Report Number
    1416980-2014-08045
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    February 13, 2014
    Report Date
    February 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AN ALARM INDICATIVE OF A POTENTIAL MALFUNCTION OF THE DISPOSABLE CASSETTE WAS IDENTIFIED. THE CASSETTE IS REPORTED TO BE AVAILABLE FOR EVALUATION, AND A REQUEST FOR ITS RETURN HAS BEEN MADE. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION ALONG WITH TWO SOLUTION BAGS (L5B9771 AND C927152) AND TWO ANCILLARY SETS (L5B9770 AND C923094) WHICH WERE CONNECTED TO PATIENT AND DRAIN LINE LEADS. THE DEVICE WAS DISINFECTED. VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. LEAK TESTING, CLEAR PASSAGE TESTING, AND CLAMP FUNCTION TESTING PERFORMED WITH NO ISSUES NOTED. THE SAMPLE WITH BAGS, FRANGIBLE ASSEMBLY, PATIENT AND DRAIN LINES WERE THEN RAN ON AN IN-HOUSE HOMECHOICE MACHINE WITH NO ISSUES NOTED. THE EVALUATION DID NOT CONFIRM THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD A SYSTEM ERROR 2240 (AIR IN LINE) ON THE HOMECHOICE (HC) DEVICE DURING THE INITIAL DRAIN, WHILE THE HP WAS CONNECTED. NOTHING WAS FOUND DURING TROUBLESHOOTING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ALARM. IT IS UNKNOWN WHETHER THE PATIENT LINE WAS PROPERLY PRIMED BEFORE CONNECTING, AS THE HP DID NOT CHECK BEFORE CONNECTING. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE HP CLOSE THE CLAMPS, CYCLE THE POWER ON THE HC DEVICE, DISCONNECT, AND REMOVE THE SUPPLIES. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, 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
    142251 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H13K15050

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE| DIANEAL LOW CALCIUM 2.5% DEXTROSE 6L| DIANEAL LOW CALCIUM 1.5% DEXTROSE 6L