BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3221977 · Received July 5, 2013

    Report

    Report Number
    1314492-2013-01040
    Event Type
    Malfunction
    Date Received
    July 5, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 7, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION AND THEREFORE AN EVALUATION COULD NOT BE COMPLETED. IF THE DEVICE IS RETURNED, AN EVALUATION WILL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) CLOTTED WHILE IN USE WITH A SPECTRUM PUMP. THIS EVENT OCCURRED IN THE NICU (NEONATAL INTENSIVE CARE UNIT) AND IS AN ONGOING ISSUE AT THIS HOSPITAL. THE CLOTTING OCCURRED WHILE INFUSING D10 NORMAL SALINE WITH HEPARIN (1 UNIT/ML) AT A RATE OF 1 ML/HR. IT IS UNCLEAR AS TO WHETHER OR NOT THE PUMP ALARMED FOR DOWNSTREAM OCCLUSION WHEN THE PICC CLOTTED. THE PUMPS WERE ORIGINALLY WAIST HIGH, WITH THE IV LINE RUNNING OVER THE TOP OF THE CRIBS, BUT THEY HAVE RAISED THEIR PUMPS IN AN ATTEMPT TO PREVENT CLOTTING. THE SET WAS IN THE PUMP FOR AT LEAST 12 HOURS PRIOR TO CLOTTING AND THERE IS "A LOT" OF TUBING LOOPING DOWNSTREAM OF THE DEVICE. THE PICC HAD TO BE RE-INSERTED INTO THE PT, BUT THE CUSTOMER STATED THERE WAS NO INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307605 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 BAXTER FILTER ((B)(4))| BARD PICC LINE ((B)(4))| BAXTER BURETROL SET ((B)(4))| BAXTER NON-DEHP Y-CONNECTOR ((B)(4))