BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2850799 · Received November 23, 2012

    Report

    Report Number
    3003464075-2012-00088
    Event Type
    Injury
    Date Received
    November 23, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CARTRIDGE LOT # 2067735 WAS RETURNED AND EVALUATION CONFIRMED THAT THE MALE LUER OF A SYRINGE BROKE OFF IN THE ARTERIAL PRIMING LINE ON THE SALINE SPIKE. THIS APPEARS TO BE A RANDOM EVENT. THERE WAS NO PROBLEM REPORTED WITH DISCONNECT OF THE PATIENT BLOOD LINE FROM THE SAME SALINE SPIKE CONNECTOR PRIOR TO STARTING THE TREATMENT. CARTRIDGE CONTAINS STANDARD LUER COMPONENTS WIDELY USED THROUGHOUT DIALYSIS INDUSTRY. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED.

    Description of Event or Problem · 1

    AT RINSE BACK OF A ROUTINE HEMODIALYSIS TREATMENT THE OPERATOR WAS UNABLE TO CONNECT THE PATIENT ARTERIAL BLOOD LINE TO THE SALINE SPIKE/PORT BECAUSE THE MALE LUER OF ANOTHER MANUFACTURER'S SYRINGE BROKE OFF AT THE SALINE SPIKE/PORT. OPERATOR DID NOT RINSE BACK AND PATIENT HAD A 190 CC BLOOD LOSS. POST EVENT, HB WAS 9.6. PATIENT'S EPOGEN DOSE WAS INCREASED TO 15,000 UNITS PER WEEK FROM 15,000 UNITS EVERY OTHER WEEK. NO OTHER MEDICAL INTERVENTION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-170-C 2067735

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R