BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP

    MDR report key: 9437210 · Received December 9, 2019

    Report

    Report Number
    3011581906-2019-00045
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 15, 2019
    Report Date
    November 25, 2019
    Manufacturer
    INFUTRONIX, LLC
    Product Code
    FPA
    UDI-DI
    00817170020031
    PMA / PMN Number
    K153193
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGES OF THE AFFECTED ADMINISTRATION SET AS IT WAS RECEIVED BY (B)(4) WERE PROVIDED ON 11/27/2019. THE LOCATION WHERE THE TUBING CONNECTS TO THE CASSETTE HAD BEEN BROKEN AND DETACHED. THE LOT NUMBER OF THE AFFECTED ADMINISTRATION SET WAS UNKNOWN. HOWEVER, BASED OFF THE IMAGES OF THE ADMINISTRATION SET PROVIDED BY THE DISTRIBUTOR, THIS ADMINISTRATION SET WAS MANUFACTURED WITH THE NEW DESIGN OF THE CASSETTE CONNECTION. THE DISTRIBUTOR CONFIRMED THAT THE ONLY ADMINISTRATION SETS WITH THE NEW DESIGN SENT TO THE END USER WERE FROM LOT # 1903007. FURTHER INVESTIGATION FOUND THAT THIS LOT # 1903007 WAS ALSO TESTED AS PART OF A SCAR BY THE CONTRACT MANUFACTURER. THIS LOT # 1903007 WAS TESTED TO TENSILE STRENGTH REQUIREMENTS PER ISO 8536-9(2015) AND PASSED ALL TESTING CRITERIA. THIS LEADS TO THE CONCLUSION THAT THE BROKEN ADMINISTRATION SET CONNECTION WAS DUE TO EXCESSIVE PHYSICAL FORCE.

    Description of Event or Problem · 1

    ON 11/25/2019, A DISTRIBUTOR OF INFUTRONIX REPORTED A TUBING LEAKING ISSUE: "STOPPED INFUSION ABOUT 8 HOURS INTO A 46 HOUR INFUSION. THE PT. STATED THAT SHE THOUGHT THE BAG WAS LEAKING SO SHE DOUBLE BAGGED EVERYTHING. WHEN SHE CAME IN THIS MORNING, THE BAG OF 5FU HAD LEAKED AND WAS COMPLETELY EMPTY. THE PLASTIC CONNECTOR BETWEEN THE TUBING ON THE OUTSIDE OF THE CASSETTE AND THE TUBING INSIDE OF THE CASSETTE HAD BROKEN." THE CONTRACT MANUFACTURER OF THE AFFECTED DEVICE IS PODO XINGDA (TIANJIN) MEDICAL CO. LTD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1236621 ADMINISTRATION SET FOR HALO II AMBULATORY INFUSION PUMP IV ADMINISTRATION SET FPA INFUTRONIX, LLC HS-004 1903007 00817170020031

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR