BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE M.T INFUSION PUMP- US

    MDR report key: 6065902 · Received October 30, 2016

    Report

    Report Number
    3010293992-2016-00240
    Event Type
    Malfunction
    Date Received
    October 30, 2016
    Date of Event
    September 9, 2016
    Report Date
    October 5, 2016
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    07290109150109
    PMA / PMN Number
    K141389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    DISTRIBUTOR INFORMATION: ICU MEDICAL, INC. US SERVICE CENTER SAN JOSE, CA 95138. EXEMPTION NUMBER: E2014005. Q CORE MEDICAL LTD (MANUFACTURER) IS SUBMITTING THE REPORT ON BEHALF OF ICU MEDICAL.

    Additional Manufacturer Narrative · 0

    (B)(4). EXEMPTION NUMBER, E2014005.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: OVER DELIVERY.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "SAPPHIRE PUMP OVER INFUSION- IT HAS BEEN REPORTED THAT 3 SAPPHIRE PUMPS HAVE BEEN OVER INFUSING OUT OF THE +/-2.5 SPECIFICATION. ORIGINAL BAG SAVED AND USED (NOT TUBING). RAN ON SAME PROGRAM PUMP WAS ON FOR 3 DAYS. VI 14.8ML, ACTUAL DELIVERY 19ML, EXCEEDED HOSPIRA ALLOWABLE VARIANCE OF +/-2.5%. ALARM SETTINGS: OCCLUSION UNITS PSI, OCCLUSION PRESSURE 10PSI, PUMP UNATTENDED 2 MIN, INFUSION NEAR END 10 MIN, ALARM VOLUME MAX. TYPE OF DRUG:FENTANYL. KINDLY ACKNOWLEDGE NO HUMAN HARM CAUSED. CAUSED NO HUMAN HARM. WHAT WERE THE TREATMENT SETTINGS?VI 14.8ML, ACTUAL DELIVERY 19M. TYPE OF DRUG: FENTANYL. PUMP TREATMENT INFORMATION: CONC 10:1MG/ML, RATE 0, BOLUS 10MCG, 10 MIN LOCKOUT, 6 BOLUSES/HR VTBI: 14.8? (VI 100ML 14.8ML WAS FROM MY TESTING). WHAT WAS THE PRESSURE (OCCLUSION) SENSOR SETTING (0.4-1.2 BAR)? 10PSI. WHAT WAS THE INITIAL BAG VOLUME? 100ML. QUESTION:[OCT-11-2016 9:59 AM (IDT) (B)(4)] QUESTION 2 :NO NEED FOR AN ANSWER-13.2. ANSWER:[OCT-14-2016 4:43 PM (IDT) (B)(6)]. QUESTION NO. 2 WAS PROVIDED IN THE INTAKE FORM. PATIENT INVOLVEMENT: YES. HUMAN HARM: NO. MEDICAL INTERVENTION NEEDED: NO. EVENT OCCURED DURING PATIENT USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716791 SAPPHIRE M.T INFUSION PUMP- US INFUSION PUMP FRN Q CORE MEDICAL LTD. 07290109150109

    Patients

    Seq Age Sex Outcome Treatment
    1