BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2925453 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01647
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS UNAVAILABLE. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT ARE UNKNOWN; IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INFORMATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE THERE WAS NO SAMPLE RETURNED TO BAXTER FOR EVALUATION. A BATCH REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING THE HOME PATIENT (HP) COULD NOT CONNECT OR PRIME ON A HOME CHOICE (HC). THE HP STATED THERE WAS SOMETHING PREVENTING HIM FROM CONNECTING THE PATIENT LINE TO THE TRANSFER SET. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO END THE SET UP AND START OVER WITH NEW SUPPLIES. THE HP STATED HE WAS TRAVELING TO FLORIDA IN A COUPLE OF DAYS AND DID NOT WANT A SHIPPING KIT. THE TST ASSISTED WITH ENDING THERAPY AND ADVISED THE HP TO DISPOSE OF ALL THE CURRENT SUPPLIES AND START OVER WITH ALL NEW SUPPLIES. PRODUCT SURVEILLANCE (PS) SPOKE WITH THE PERITONEAL DIALYSIS NURSE (PDN) ON (B)(4) 2013 REGARDING THE CONNECTION ISSUE. THE PDN STATED THE HOME PATIENT (HP) DID CALL HER REGARDING THIS AND THAT SHE FELT THERE WAS NOTHING WRONG WITH THE SUPPLIES AND THE HP WAS ABLE TO RESUME THERAPY USING NEW SUPPLIES ON THE CYCLER. THE PDN STATED THE HP WAS DOING FINE WITH THERAPY ON THE CYCLER. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29187 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR HOMECHOICE| CASSETTE