BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    81 CM (32") APPX 5.1 ML, 20 DROP BLOOD SET W/200 MICRON FILTER, ROTATING LUER, B

    MDR report key: 9106674 · Received September 23, 2019

    Report

    Report Number
    9617594-2019-00312
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Date of Event
    September 1, 2019
    Report Date
    September 6, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FJK
    UDI-DI
    00840619004699
    PMA / PMN Number
    K983559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: RECEIVED ONE NEW LIST # 011-C6028, 81 CM (32") APPX 5.1 ML, 20 DROP BLOOD SET W/200 MICRON FILTER, ROTATING LUER, BAG HANGER; LOT # 4040339 ON OCTOBER 1, 2019 IN SALT LAKE CITY FOR INVESTIGATION. THE SET WAS RECEIVED IN A SEALED PACKAGE. NO DAMAGE OR ANOMALIES WERE IDENTIFIED ON THE PACKAGING. THE SET WAS REMOVED FROM THE PACKAGING AND INSPECTED. NO DAMAGE OR ANOMALIES WERE IDENTIFIED ON THE SET. THE SET WAS LEAK TESTED AND PASSED THE PRODUCT PERFORMANCE SPECIFICATION. NO LEAKAGE WAS OBSERVED. THE COMPLAINT OF LEAKAGE COULD NOT BE CONFIRMED. A DEVICE HISTORY REVIEW (DHR) LOT #4040339 REVIEW WAS CONDUCTED AND THERE WERE NO NON CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURNED DEVICE A PROBABLE CAUSE CANNOT BE ESTABLISHED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED ON AN UNKNOWN DATE. THE EVENT INVOLVED A DROP BLOOD SET W/200 MICRON FILTER, ROTATING LUER, BAG HANGER THAT THE CUSTOMER REPORTED AN UNSPECIFIED CHEMOTHERAPY LEAKED FROM SECONDARY GIVING SET CAUSING A LARGE CHEMOTHERAPY SPILL. THE SECONDARY GIVING SET TUBING FELL AWAY FROM THE COUNT CHAMBER ALLOWING CHEMOTHERAPY TO SPILL TO THE FLOOR. THE CHEMOTHERAPY SPILL WAS MANAGED BY THE NURSING STAFF PER LOCAL AREA PROCEDURE. THE PATIENT'S DRUG HAD TO BE MADE AND RE-ISSUED FROM THE PHARMACY. THE OUTCOME HAS NO APPARENT INJURY TO PATIENT OR STAFF BUT THE STAFF MAY HAVE BEEN EXPOSED TO THE CHEMOTHERAPY DRUG DURING THE LARGE SPILL CLEAN UP. THERE WAS PATIENT INVOLVEMENT, HOWEVER NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901820 81 CM (32") APPX 5.1 ML, 20 DROP BLOOD SET W/200 MICRON FILTER, ROTATING LUER, B SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE FJK ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4040339 00840619004699

    Patients

    Seq Age Sex Outcome Treatment
    1