BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA SPECTRUM INFUSION PUMP

    MDR report key: 2202393 · Received August 10, 2011

    Report

    Report Number
    1314492-2011-00033
    Event Type
    Injury
    Date Received
    August 10, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    SIGMA LLC
    Product Code
    FRN
    Removal / Correction Number
    1314492-09/13/10-003-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED TO SIGMA UNDER RECALL 1314492-09/13/10-003-R. UPON INITIAL EVALUATION IN SERVICE, IT WAS OBSERVED THAT THE LOWER BEARING HAD FAILED. SIGMA REQUESTED INFORMATION FROM THE CUSTOMER RELATING TO ANY INCIDENCES WITH THIS PUMP. THE CUSTOMER REPORTED NO COMPLAINTS OR SERVICE REQUESTS, FOR THIS PUMP, IN THEIR RECORDS. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA SPECTRUM INFUSION PUMP INFUSION PUMP FRN SIGMA LLC 35700

    Patients

    Seq Age Sex Outcome Treatment
    1