BEUDAMED
    FDA Adverse Event Summary report: N

    Q CORE SAPPHIRE EPIDURAL INFUSION PUMP

    MDR report key: 4790351 · Received May 21, 2015

    Report

    Report Number
    3010293992-2015-00044
    Date Received
    May 21, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 6, 2015
    Manufacturer
    Q CORE MEDICAL LTD
    Product Code
    FRN
    PMA / PMN Number
    K123049
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). Q QORE MEDICAL LTD. IS SUBMITTING THE REPORT ON BEHALF OF HOSPIRA. (B)(4).

    Description of Event or Problem · 1

    EVENT AS DESCRIBED BY THE USER: "DR. (B)(6) ON (B)(6) 2015 INDICATED THAT THE ANESTHESIA GROUP USED UPDATED SAPPHIRE EPIDURAL PUMPS (RECONFIGURED WITH NEW CONFIGURATION SETTINGS RECOMMENDED ON (B)(6) 2015 AND HAD UPDATED SOFTWARE ON (B)(6) 2015) OVER THE WEEKEND AND ARE CONTINUING TO HAVE BAGS RUN DRY BEFORE VTBI REACHES ZERO. HE STATED THAT (B)(6) CONCERN IS NOW THAT THERE IS A "SERIOUS THREAT TO PATIENT SAFETY" AS THESE PUMPS ARE DELIVERING AN INCORRECT DOSE. THIS CONCERN IS WITH THEIR 100ML BAGS OF MARCAIN/2MCG/1ML FENTANYL MEDICATION BAGS COMPOUNDED BY (B)(6); THE 150ML BAGS OF MEPERIDINE ARE PROGRAMMED TO RUN DRY"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331536 Q CORE SAPPHIRE EPIDURAL INFUSION PUMP INFUSION PUMP FRN Q CORE MEDICAL LTD EPIDURAL PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1