BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 2910816 · Received January 8, 2013

    Report

    Report Number
    1314492-2013-00003
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 10, 2012
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO SIGMA FOR EVAL AND THEREFORE AN EVAL COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVAL WILL BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVAL WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AT THIS TIME, THE DATE OF EVENT IS UNK. THIS REPORT IS RELATED TO MFR REPORT NO: 1315592-2013-00001, 1315592-2013-00002, 1315592-2013-00004, 1315592-2013-00005, 1315592-2013-00006, 1315592-2013-00007 AND 1315592-2013-00008.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 8 PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINES CLOTTED WHILE SPECTRUM PUMPS WERE DELIVERING MEDICATION TO THE CUSTOMERS "SMALLEST PTS" (LESS THAN (B)(6)). THE CUSTOMER EXPRESSED CONCERN WITH DELIVERING AT RATES LESS THAN 3 ML/HR ON LARGE VOLUME INFUSION PUMPS. THE CUSTOMER ALSO STATED THAT THE PICC LINES ARE "VYGON 1FR. 28GAUGE" AND "ARGON 1.9 FR. 26GAUGE" SETS. ONE FILTER IS USED ON THE MAIN LINE, AND ONE ON THE EXTENSION SET. THE ADMINISTRATION SETS WERE CHANGED EVERY 24 HOURS. NO BLOOD WAS OBSERVED PRIOR TO THE LINE CLOTTING OFF, AND THE DOWNSTREAM PRESSURE SETTING ON THE SPECTRUM PUMP WAS MOST LIKELY SET TO "MEDIUM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10040 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP. 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 Other