BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX)

    MDR report key: 8069126 · Received November 14, 2018

    Report

    Report Number
    3011581906-2018-00025
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    October 24, 2018
    Report Date
    October 24, 2018
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    UDI-DI
    00817170020031
    PMA / PMN Number
    K132841
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INFUTRONIX RECEIVED THE EVALUATION REPORT FROM THE DISTRIBUTOR ON (B)(6) 2018. THE REPORTED LEAKING ISSUE WAS CONFIRMED. A WHITE RESIDUE ON THE TUBING WAS OBSERVED ON THE ADMINISTRATION SET, INDICATING A 5FU LEAK. WATER WITH RED DYE WAS USED TO TEST THE SET FOR A SPECIFIC LEAKING SITE AND LEAKING SITES WERE IDENTIFIED AT BOTH THE DISTAL CONNECTOR OF THE CASSETTE AND THE PROXIMAL CONNECTOR TO THE AIR FILTER. THE DISTRIBUTOR SCRAPPED THE AFFECTED ADMINISTRATION SET AND DID NOT RETURN IT TO INFUTRONIX FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP FOR THE INITIALLY FILED MDR (3011581906-2018-00025).

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE IS NOT YET RETURNED TO THE DISTRIBUTOR OF INFUTRONIX.

    Description of Event or Problem · 1

    A DISTRIBUTOR INFORMED INFUTRONIX ON (B)(6) 2018 OF A LEAKING ISSUE OF THE ADMINISTRATION SET THAT WAS REPORTED BY AN INITIAL REPORTER: "SHE STATED THAT SHE HAD A PATIENT COME BACK TO THE CLINIC TODAY AND SHE NOTICED 5FU LEAKED OUT OF THE SET (SHE SAID THE BAG WAS WET AND THERE WAS WHITE POWDER ON THE TUBING AND PUMP). SHE SAID IT APPEARED TO BE WHERE THE SET AND THE PLASTIC PIECE COME TOGETHER BUT SHE COULDN'T CONFIRM IT. THE LEAK OCCURRED DURING THE INFUSION. SHE STATED THAT THERE WAS NO PATIENT INJURY". THE EVENT DATE IS (B)(6) 2018. THE LOT NUMBER INFORMATION WAS NOT AVAILABLE. THE MEDICATION USED AT THE TIME OF EVENT IS 5FU. THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA ((B)(4)) MEDICAL CO. LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909116 ADMINISTRATION SET FOR HALO AMBULATORY INFUSION PUMP (TRADE NAME NIMBUS FLEX) IV ADMINISTRATION SET FPA INFUTRONIX, LLC HS-004 UNKNOWN 00817170020031

    Patients

    Seq Age Sex Outcome Treatment
    1