BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3223891 · Received July 2, 2013

    Report

    Report Number
    1314492-2013-00959
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED BY BAXTER. THE BAXTER EVAL COULD NOT REPRODUCE THE REPORTED SYMPTOM BUT CONFIRMED THE OCCURRENCE OF SYSTEM ERROR 322 THROUGH HISTORY LOG REVIEW. FURTHER EVAL FOUND THE UPPER LATCH SWITCH TO BECOME INTERMITTENTLY OPEN WHICH COULD CAUSE THE SYSTEM ERROR 322. THE UPPER AUXILIARY FLEX WILL BE REPLACED. SYSTEM ERROR 322 WILL OCCUR WHEN THE PUMP TRANSITIONS FROM THE DOOR OPEN STATE TO THE DOOR CLOSED/SET-LOADED STATE AND THE LOWER LINK SWITCH DOES NOT ACTIVATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PUMP HAS ALARMED SYSTEM ERROR 322 MULTIPLE TIMES. THE CUSTOMER STATED THERE WAS NO PT INJURY AND THE DEVICE WAS BEING USED IN THE CCU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300617 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1