BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL VLV ADPT(STAND ALONE)

    MDR report key: 11004060 · Received December 14, 2020

    Report

    Report Number
    9616066-2020-20565
    Event Type
    Malfunction
    Date Received
    December 14, 2020
    Date of Event
    November 2, 2020
    Report Date
    December 15, 2020
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A 2000E CHINA PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 19095319. THE CUSTOMER FEEDBACK INDICATES THAT LEAKAGE WAS OBSERVED BETWEEN THE SMARTSITE AND THE CONNECTING PRODUCT; NO DAMAGE WAS OBSERVED TO THE PRODUCT. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 19095319 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LL VLV ADPT(STAND ALONE) LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE RESPONSIBLE NURSE FOUND THAT THE PLASTIC PART WAS LEAKING OUT WHILE PERFORMING THE INTRAVENOUS INFUSION CONNECTION JOINT IN THE MORNING, AND THE INFUSION COULD NOT BE CARRIED OUT. AFTER FINDING IT, IT WAS REPLACED IN TIME."

    Additional Manufacturer Narrative · 1

    2000E (B)(6) 510K: THIS IS AN INTERNATIONAL CODE- THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS 2000E. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT.- K960280. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LL VLV ADPT (STAND ALONE) LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE RESPONSIBLE NURSE FOUND THAT THE PLASTIC PART WAS LEAKING OUT WHILE PERFORMING THE INTRAVENOUS INFUSION CONNECTION JOINT IN THE MORNING, AND THE INFUSION COULD NOT BE CARRIED OUT. AFTER FINDING IT, IT WAS REPLACED IN TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1466402 LL VLV ADPT(STAND ALONE) INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 19095319

    Patients

    Seq Age Sex Outcome Treatment
    1