BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 2510559 · Received March 27, 2012

    Report

    Report Number
    3003464075-2012-00016
    Event Type
    Injury
    Date Received
    March 27, 2012
    Date of Event
    February 27, 2012
    Report Date
    February 27, 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

    THE CARTRIDGE WAS NOT RETURNED TO NXSTAGE, HOWEVER, FACILITY STAFF EXAMINED THE CARTRIDGE AND CONFIRMED THE VENOUS PT BLOOD LINE WAS CONNECTED TO THE SALINE BAG INSTEAD OF THE ARTERIAL PT BLOOD LINE. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. FACILITY STAFF ATTRIBUTE EVENT TO USE ERROR NOT FOLLOWING CORRECT PROCEDURES FOR CARTRIDGE RINSEBACK CONNECTIONS. RE-TRAINING HAS BEEN PROVIDED TO THE OPERATOR. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    FOLLOWING THE NEED OF A ROUTINE HEMODIALYSIS TREATMENT, THE VENOUS PT BLOOD LINE WAS ATTACHED TO THE SALINE BAG INSTEAD OF THE ARTERIAL PT BLOOD LINE RESULTING IN THE RINSEBACK BLOOD VOLUME RETURNING TO THE SALINE BAG INSTEAD OF THE PT. PT REPORTED FELLING LIKE SHE WAS PASSING OUT. NINE-ONE-ONE WAS CALLED AND THE PT WAS TRANSPORTED TO THE HOSPITAL. PT RECEIVED UNK VOLUME OF SALINE AND RELEASED. HB WAS 10.2 OR 10.6 ONE WEEK PRIOR TO EVENT. HB AT ED WAS 9.1, THEN 8.1, ON (B)(6) 2012. EPOGEN DOSE WAS INCREASED TO 5200UNITS 2X/ WEEK FROM 2600 UNITS 2X/WEEK. NO OTHER MEDICAL INTERVENTION 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-B 1117723

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| O| R