BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAPPHIRE M.T INFUSION PUMP- US

    MDR report key: 5774410 · Received July 7, 2016

    Report

    Report Number
    3010293992-2016-00165
    Event Type
    Injury
    Date Received
    July 7, 2016
    Date of Event
    June 16, 2016
    Report Date
    December 7, 2017
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTOR INFORMATION: (B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF (B)(4). EXEMPTION NUMBER, E2014005.

    Additional Manufacturer Narrative · 0

    (B)(4). Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL. EXEMPTION NUMBER, E2014005.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "INTERVENTION REQUIRED TO SUSTAIN LIFE- EVENT @ 18:30 - LOCATION (B)(4)-PATIENT RETURNED TO UNIT POST OP, ACCOMPANIED BY ANESTHESIA. PT NOTED TO BE UNABLE TO RESPOND - EYES OPEN, TACHYCARDIC. RN NOTICED THAT PCA DILAUDID HAD BEEN TURNED OFF, ANESTHESIA MD INDICATED IT HAD RUN DRY AS THE PT WAS EXTUBATED. AT LAST READING PCA HAD 73.3 ML REMAINING & WAS INFUSING AT 5 ML/HR. CONFIRMED PROGRAM: CONCENTRATION: 0.02MG/ML, RATE: 1 MG/HR, BOLUS: 0.02 MG Q 15 MINUTES, LOCKOUT: 4 BOLUSES PER HOUR. PCA NOW INDICATES 12.3 ML REMAINING - IV BAG IS COMPLETELY EMPTY. LAST READING AT 14:42, PT RETURNED FROM OR AT 1830 BAG EMPTY, RATE OF 5 ML/HR PROGRAMED INTO PUMP. SIXTY ONE (61) ML REMAINING AT 14:42 SHOULD HAVE TAKEN 12.2 HOURS TO INFUSE. PUMP READOUT INDICATED ONLY 1 BOLUS GIVEN 14:42 - 18:30. ATTENDING PHYSICIAN NOTIFIED. PATIENT EMERGENTLY INTUBATED. MONITORED PER ICU ROUTINES. DEVICE SEQUESTERED AND TO BE GIVEN TO BIOMEDICAL DEPARTMENT FOR ANALYSIS. DELAY IN THERAPY:UNKNOWN. NEED FOR MEDICAL INTERVENTION: YES. HUMAN HARM: YES."

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: SUSPECTED ACCURACY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430420 SAPPHIRE M.T INFUSION PUMP- US INFUSION PUMP FRN Q CORE MEDICAL LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention