BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 3935416 · Received February 3, 2014

    Report

    Report Number
    1314492-2014-05651
    Event Type
    Malfunction
    Date Received
    February 3, 2014
    Date of Event
    January 1, 2014
    Report Date
    January 7, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND EVALUATED. THE EVALUATION REPRODUCED THE REPORTED SYSTEM ERROR 322. PHYSICAL INSPECTION FOUND THAT THE MECHANICAL MOUNT SCREW THAT HOLDS THE UPPER AUXILIARY BRACKET WAS LOOSE ALLOWING THE UPPER LATCH SWITCH TO MOVE IN AND OUT FROM THE UPPER DOOR LATCH CAUSING IT TO BE OUT OF SPECIFICATION. THE LOOSE MECHANICAL MOUNT SCREW WILL TRIGGER AN INTERMITTENT OPEN/CLOSED SWITCH CONNECTION CAUSING THE REPORTED SYSTEM ERROR 322. THE UPPER AUXILIARY ASSEMBLY WAS 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 A SYSTEM ERROR 322. IT WAS ALSO REPORTED THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71487 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1