BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADD LEGACY PUMP 1.5MG SDV

    MDR report key: 7914257 · Received September 26, 2018

    Report

    Report Number
    MW5080155
    Event Type
    Injury
    Date Received
    September 26, 2018
    Date of Event
    September 13, 2018
    Report Date
    September 13, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS IBC FROM (B)(6), RN AT (B)(6) HEALTH REQUESTING DOSING INFO FOR PT. PROVIDED CURRENT DOSING VELETRI INFO. PT CURRENTLY IN THE ER DUE TO HER BEING TOLD TO COME IN AFTER REPORTING PUMP MALFUNCTION. PT'S PUMP (B)(4) IS MALFUNCTIONING INDICATING HIGH PRESSURE ON DISPLAY. NO KINKS IN LINE / BLOCKAGE AND TUBING WAS SWITCHED. NO OTHER INFO IS KNOWN. THE REPORTED PRODUCT FAULT OCCURRED WHILE IN USE WITH A PT. THE PRODUCT ISSUE DID NOT CAUSE OR CONTRIBUTE TO PT OR CLINICAL INJURY. WE DID REPLACE THE DEVICE. DATES OF USE: FROM (B)(6) 2017 TO CURRENT. DIAGNOSIS OR REASON FOR USE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752086 CADD LEGACY PUMP 1.5MG SDV PUMP INFUSION FRN SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization