BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q CORE SAPPHIRE EPIDURAL INFUSION PUMP

    MDR report key: 4791492 · Received May 21, 2015

    Report

    Report Number
    3010293992-2015-00025
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Date of Event
    April 15, 2014
    Report Date
    April 16, 2014
    Manufacturer
    Q CORE MEDICAL LTD
    Product Code
    FRN
    PMA / PMN Number
    K123049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). Q CORE MED LTD IS SUBMITTING THE REPORT ON BEHALF OF (B)(4).

    Description of Event or Problem · 1

    EVENT AS REPORTED BY THE USER: "THE PUMP HAD AIR IN LINE ALARM; THE SOLUTION BAG WAS COMPLETELY DRY AND EMPTY. THE PUMP SHOWED VOLUME TO BE INFUSED EVEN THE BAG IS ALREADY EMPTY. THERE WERE NO DETAILS OF EXACT VOLUME TO BE INFUSED; THEY SUSPECTED THAT THE NURSE PROGRAMMED IT INCORRECTLY HAS PT INVOLVEMENT; NO ADVERSE EVENTS; NO DELAY IN THERAPY; NO NEED FOR MEDICAL INTERVENTION. THERE ARE SPARE PUMPS AVAILABLE IN THE FACILITY. IT WAS AFFIRMED THAT HE WOULD BE INFORMED IF THERE WERE UNDESIRABLE EVENTS THAT OCCURRED. IN THIS CASE, HE WAS NOT. THE PUMP IS NOT RETURNING TO THE PLANT SINCE IT IS STILL USED ON THE CLINICAL FLOOR." ADDITIONAL INFORMATION: CUSTOMER CONFIRMED NO FURTHER ISSUES WITH THE PUMP: "I HAVE RECEIVED INFO FROM THE CUSTOMER STATING THAT NO FURTHER PROBLEMS WITH THE PUMP WERE EXPERIENCED." AT THE TIME OF THE INITIAL COMPLAINT THE FIRM DID NOT HAVE SUFFICIENT INFO ON THE CLINICAL RELEVANCE OF THE BIOMED TEST METHODS TO CONCLUDE IF THERE IS A POTENTIAL FOR PT HARM. MORE INFORMATION BECAME AVAILABLE BASED ON THE ADD'L COMPLAINTS REC'D AND THE INVESTIGATION OF THE CONDITION THAT LED TO THE CONCLUSION THAT THE POTENTIAL FOR PT HARM EXISTS, THEREFORE, REPORTABILITY DECISION WAS RE-ASSESSED AND THE FIRM BELIEVES THESE COMPLAINTS ARE REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331012 Q CORE SAPPHIRE EPIDURAL INFUSION PUMP INFUSION PUMP FRN Q CORE MEDICAL LTD EPIDURAL PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1