BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3250758 · Received July 19, 2013

    Report

    Report Number
    1314492-2013-01546
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR REF NO.: (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVAL IS IN PROGRESS. WHEN THE EVAL IS COMPLETE A SUPPLEMENTAL REPORT WILL BE SUBMITTED. REFERENCE REPORT NUMBERS 1314492-2013-XXXXX, XXXXX, XXXXX FOR ADD'L MALFUNCTIONS REPORTED DURING THE SAME INFUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INFUSION OF GLUCOSE IN THE NICU A PUMP EXPERIENCED A SYSTEM ERROR 322. THE CUSTOMER STATED THE CLINICIAN OPENED THE DOOR AND CHANGED OUT THE IV SET. UPON RE-CLOSING THE DOOR THE PUMP EXPERIENCED A SYSTEM ERROR 322. THE CUSTOMER STATED THE PT WAS A NEONATE AND THE ALARM OCCURRENCES RESULTED IN THE PT EXPERIENCING "LIFE THREATENING LOW GLUCOSE LEVELS." THE CLINICIANS WERE ABLE TO BRING THE NEONATES SUGAR LEVELS BACK UP THROUGH THE ADMINISTRATION OF A D10 BOLUS TO THE PT AND WITHIN AN HR THE BABY'S SUGAR WAS BACK UP. THE CUSTOMER STATED THEY BELIEVE THE PROBLEM WAS RELATED TO THE TUBING AND NOT TO THE PUMP. THE CUSTOMER ALSO STATED THERE WAS AN INDENTATION OR KINK JUST BELOW THE BURETROL CONTAINER ON THE INVOLVED IV SET AND THAT THE IV SET WAS STILL PATENT FOLLOWING THE EVENT. IT WAS ALSO STATED THE CUSTOMER RAN PREVENTATIVE MAINTENANCE TESTING ON THE PUMP FOLLOWING THE EVENT WITH PASSING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339166 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R BAXTER IV SET 2C8864