BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP213-01

    MDR report key: 5415508 · Received February 7, 2016

    Report

    Report Number
    3010293992-2016-00036
    Event Type
    Malfunction
    Date Received
    February 7, 2016
    Date of Event
    January 6, 2016
    Report Date
    January 7, 2016
    Manufacturer
    Q CORE MEDICAL LTD.
    Product Code
    FPA
    PMA / PMN Number
    K141834
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

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

    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.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: "PT AWAKENED TO FIND A DIME SIZE AREA ON SHIRT AND COMFORTER OF YELLOW DRIED LIQUID. WIFE (WHO IS A HOSPICE RN) PUT ON GLOVES AND CHECKED ENTIRE LENGTH OF TUBING HOWEVER NO LEAKING FOUND. PT STATES AREA ON SHIRT IS NEAR WHERE THE BLUE MEDICATION PORT IS. PT CONNECTED TO DOXORUBICIN AT 4:30PM YESTERDAY. DOES NOT HAVE CLINIC APPT TODAY HOWEVER VNA MAKING VISIT FOR BLOOD RETURN CHK. PT DOES NOT KNOW TIME OF VISIT. INSTR TO WASH SKIN WHERE LEAKING OCCURRED THOROUGHLY. STATES NO ISSUE WITH SKIN. MED CONTINUES TO INFUSE WITHOUT ANY SIGN OF LEAK. INSTR PT TO PLACE PAPER TOWEL THEN SARAN WRAP AROUND AREA OF BLUE MED PORT TO SEAL IT OFF. INSTR TO CHK AREA EVERY FEW MINUTES FOR LEAKING AND SHUT OFF PUMP IMMED IF SEEN. NO PATIENT HARM. DOXORUBICIN 171 MG IN SALINE. TOTAL VOLUME 210 ML. INFUSE 200 ML OVER 48 HOURS TYPE OF DRUG:DOXORUBICIN 171 MG IN SALINE. TOTAL VOLUME 210 ML. INFUSE 200 ML OVER 48 HOURS DELAY IN THERAPY:UNKNOWN; NEED FOR MEDICAL INTERVENTION:UNKNOWN; PATIENT INVOLVEMENT: YES; DEATH / SERIOUS INJURY: NO; HUMAN HARM: NO. "

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED BY A CUSTOMER FROM USA: ADMINISTRATION SET LEAKAGE OF DOXORUBICIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73672 AP213-01 ADMINISTRETION SET FPA Q CORE MEDICAL LTD. 56-197-5G

    Patients

    Seq Age Sex Outcome Treatment
    1