BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LS PRI PLUM 15 MICRON CL 0.2M PE 272CM

    MDR report key: 9134102 · Received September 30, 2019

    Report

    Report Number
    9615050-2019-00415
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    January 19, 2019
    Report Date
    July 11, 2019
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    00(01)(17)(10)
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO LIST # 140099290 PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE LOT HISTORY WAS REVIEWED AND THERE WERE NO NONCONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. A PROBABLE CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED. THE REPORTED COMPLAINT CANNOT BE CONFIRMED. POSSIBLE LOT NUMBERS 925775H (MANUFACTURING DATE 8/2018/EXPIRATION DATE 8/2021) OR 896175H (MANUFACTURING DATE 5/2018/EXPIRATION DATE 5/2021).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE INVOLVED IN THE EVENT EXPERIENCED A LEAK AT THE FILTER. ADDITIONAL INFORMATION RECEIVED ON 9/2/2019 INDICATED THE LEAK WAS OF UNKNOWN CHEMOTHERAPY OR BIOTHERAPY. THE PUMP PRESSURE WAS REPORTED TO BE SET AT STANDARD-SETTING BETWEEN 300-3015 MMHG. THERE WAS NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927965 LS PRI PLUM 15 MICRON CL 0.2M PE 272CM SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. PLOTS 00(01)(17)(10)

    Patients

    Seq Age Sex Outcome Treatment
    1