BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AP213-01

    MDR report key: 5415506 · Received February 7, 2016

    Report

    Report Number
    3010293992-2016-00034
    Event Type
    Malfunction
    Date Received
    February 7, 2016
    Date of Event
    January 5, 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 NOTED LEAKING FROM IV TUBING WHILE DRIVING TO INFUSION CENTER. AREA OF LEAK APPEARS TO BE AT BLUE MED PORT. PT INFUSING DOXORUBICIN OVER 48HR VIA TL PICC. INSTR PT TO SHUT OFF PUMP NOW AND CLAMP PICC LUMEN. VERIFIED PT IN HOSP CC PARKING LOT. INSTR PT TO OBTAIN RUBBER GLOVE AT ENTRANCE IF POSSIBLE OR PAPER TOWEL TO WRAP AROUND BLUE MED PORT TO CONTAIN ANY DRIPPING BEFORE GOING INTO CC. INSTR PT TO NOTIFY NURSING IMMED AND HAVE AREA OF LEAKING ONTO SKIN WASHED THOROUGHLY. PATIENT RECEIVED 177.4 ML OUT OF 200 ML ORDERED BEFORE LEAK DISCOVERED. INFUSION DISCONTINUED. OUTCOME: UNABLE TO OBSERVE THE LEAK UPON INSPECTION AT THE BRANCH. NO PATIENT HARM. DOXORUBICIN 109 MG IN SALINE. TOTAL VOLUME 210 ML. INFUSE 200 ML OVER 48 HOURS TYPE OF DRUG:DOXORUBICIN 109 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
    73670 AP213-01 ADMINISTRATION SET FPA Q CORE MEDICAL LTD. 561975G

    Patients

    Seq Age Sex Outcome Treatment
    1