BEUDAMED
    FDA Adverse Event Summary report: N

    Q CORE SAPPHIRE EPIDURAL INFUSION PUMP

    MDR report key: 4790324 · Received May 21, 2015

    Report

    Report Number
    3010293992-2015-00027
    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 CORE MEDICAL LTD. IS SUBMITTING THE REPORT ON BEHALF OF HOSPIRA. (B)(4).

    Description of Event or Problem · 1

    EVENT AS DESCRIBED BY THE USER: "(B)(6) ON (B)(6) 2015 INDICATED THAT THE ANESTHESIA GROUP USED UPDATED SAPPHIRE EPIDURAL PUMPS (RECONFIGURED WITH NEW CONFIGURATION SETTINGS RECOMMENDED ON 04/23/2015 AND UPDATED SOFTWARE ON 05/01/2015) 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 100 ML BAGS OF MARCIN/2MCG/1ML FENTANYL MEDICATION BAGS COMPOUNDED BY (B)(6); THE 150 ML BAGS OF MEPERIDINE ARE PROGRAMMED TO RUN DRY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331913 Q CORE SAPPHIRE EPIDURAL INFUSION PUMP INFUSION PUMP FRN Q CORE MEDICAL LTD EPIDURAL PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1