BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM

    MDR report key: 10539471 · Received September 16, 2020

    Report

    Report Number
    3005515211-2020-00004
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    August 20, 2020
    Report Date
    August 20, 2020
    Manufacturer
    AMSINO MEDICAL (SHANGHAI) CO., LTD.
    Product Code
    FMG
    UDI-DI
    00(01)(17)(10)
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SUBSEQUENT TO THE INITIAL SUBMISSION, IT WAS FOUND THAT LIST NUMBER 32.828C, OR SIMILAR DEVICE, IS NOT MARKETED IN THE U.S. BY ICU MEDICAL, INC., THEREFORE NOT COVERED BY K964435. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE MEDICAL DEVICE REPORT WAS INADVERTENTLY SUBMITTED.

    Additional Manufacturer Narrative · 1

    MANUFACTURING PLANT ADDRESS: (B)(4). A SAMPLE WAS RECEIVED FOR EVALUATION. THE INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A GRAVITY ADMINISTRATION SET, VENTED WITH CLAVE THAT THE ROLLER CLAMPS WERE TOO LOOSE TO BE HELD AT THE MIDDLE POSITION AND SOME POSITIONS WHERE THEY PREFERRED FOR THE DRIP RATE. THE CLAMPS WOULD DISPOSITION BACK TO THE UNCLAMPED STATUS, WHICH AFFECTS THEIR PRACTICE OF APPLYING THE IV SET ON THE PATIENTS AS THEY ALWAYS SET THE DRIP RATE SAY Q6, Q8, AND THEY WOULD COME BACK 6HRS OR 8HRS LATER FOR CHECKING. DUE TO THE LOOSE ROLLER CLAMP, THE SALINE TO BE DRIPPED FOR THE PATIENT RAN EMPTY EARLIER, 2-3 HOURS BEFORE THEY COME BACK FOR CHECKING. THE PATIENT WAS CONNECTED WITH AN EMPTY NS BOTTLE/BAG FOR 2-3 HOURS, BUT NO HARM AND NO MEDICAL INTERVENTION WERE REPORTED. THIS REPORT CAPTURES THE FOURTH OF FIVE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004236 SOLUTION ONLY GRAVITY IV SET, VENTED, CLAVE X1, 190 CM STOPCOCK, I.V. SET FMG AMSINO MEDICAL (SHANGHAI) CO., LTD. UNKNOWN 00(01)(17)(10)

    Patients

    Seq Age Sex Outcome Treatment
    1 NORMAL SALINE, UNK MFR| NORMAL SALINE, UNK MFR