BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE

    MDR report key: 3031589 · Received April 2, 2013

    Report

    Report Number
    1416980-2013-08169
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF THE EVALUATION OR SHOULD ANY ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE WAS RETURNED AND EVALUATED. THE REPORTED ISSUE OF A LEAK WAS CONFIRMED FROM THE SAMPLE EVALUATION AS A HOLE WAS FOUND IN THE PATIENT LINE, THE CAUSE OF THE HOLE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO HAD THEIR DISPOSABLE CASSETTE LEAK DURING PERITONEAL DIALYSIS (PD) THERAPY AND WAS SUBSEQUENTLY DIAGNOSED WITH PERITONITIS. IT WAS REPORTED THAT A LEAK WAS FOUND COMING FROM A PINHOLE IN THE CASSETTE'S PATIENT LINE. THE HP WAS HOSPITALIZED AS A PRECAUTIONARY MEASURE FOR THE LEAKING CASSETTE AND WAS DIAGNOSED WITH PERITONITIS DURING HOSPITALIZATION. THE HP WAS TREATED WITH VANCOMYCIN, 1G, INTRA-PERITONEALLY, WITH EACH THERAPY FOR 15 DAYS. PD THERAPY WAS ONGOING. THE HP WAS CONSIDERED TO BE RECOVERING FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134956 HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H12A03115

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention DIANEAL 1.5%, 2.5%, 4.25% AND HOMECHOICE