BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 4486358 · Received August 4, 2014

    Report

    Report Number
    1314492-2014-47681
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Removal / Correction Number
    Z-1484-2014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF NO: 182758. THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED. THE (B)(4)CONFIRMED (THROUGH THE HISTORY LOG) BUT DID NOT REPRODUCE THE SYSTEM ERROR 322. THE DEVICE WAS OPERATING OUT OF SPECIFICATION. PAST REPAIRS HAVE SHOWN THE UPPER AND LOWER AUXILIARIES TO BE THE FAILING COMPONENTS. THE UPPER AND LOWER AUXILIARY ASSEMBLIES WERE 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. BAXTER HAS INITIATED A CAPA TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP ALARMED SYSTEM ERROR 322. IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455782 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORP 35700

    Patients

    Seq Age Sex Outcome Treatment
    1