BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIGMA 6000+ PROG. (AB CALIBRATION)

    MDR report key: 81909 · Received April 1, 1997

    Report

    Report Number
    81909
    Event Type
    Other
    Date Received
    April 1, 1997
    Date of Event
    February 12, 1997
    Report Date
    March 27, 1997
    Manufacturer
    SIGMA
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT CLAIMED INFUSION PUMP INFUSED AT A HIGHER RATE THAN WAS PROGRAMMED. PT COMPLAINED OF PAIN WHICH WAS RELIEVED WHEN THE PUMP WAS DICONNECTED CYCLOSPORIN WAS BEING INFUSED. BIOMED TECH TESTED PUMP AFTER INCIDENT AND COULD NOT REPRODUCE ANY MALFUNCTION. DESPITE RECEIVING RETURN AUTHORIZATION FROM MFR TO RETURN PUMP FOR TESTING, NO RECORD OF THE PUMP'S RECEIPT AT SIGMA HAS BEEN REGISTERED AS OF 3/26/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 6000+ PROG. (AB CALIBRATION) INFUSION PUMP FRN SIGMA SG 6000+ PAB *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other