BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q CORE SAPPHIRE EPIDURAL INFUSION PUMP

    MDR report key: 4791475 · Received May 21, 2015

    Report

    Report Number
    3010293992-2015-00026
    Event Type
    Malfunction
    Date Received
    May 21, 2015
    Date of Event
    January 8, 2015
    Report Date
    January 9, 2015
    Manufacturer
    Q CORE MEDICAL LTD
    Product Code
    FRN
    PMA / PMN Number
    K123049
    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 HOSPIRA.

    Description of Event or Problem · 1

    EVENT AS REPORTED BY THE USER: "DURING ACCURACY TESTING AT BIOMED PUMP ATTACHED WITH 1000ML STERILE WATER SOLUTION HANGED IN AN IV POLE, NOT ON A LOCKBOX; VTBI SET: 75ML; AFTER 2 HRS AND 24 MINS PUMP ALARMED FOR COMPLETE FUSION; FLUID MEASURED IN THE CYLINDER WAS 99ML; NO PT INVOLVEMENT". 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 ADDT'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
    331978 Q CORE SAPPHIRE EPIDURAL INFUSION PUMP INFUSION PUMP FRN Q CORE MEDICAL LTD EPIDURAL PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1