BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 20025481 · Received August 22, 2024

    Report

    Report Number
    3015537318-2024-00071
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 20, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS RECEIVED IN THE INITIAL REPORT, NO DEVICE PERFORMANCE DEFICIENCY WAS ALLEGED. THE CAUSE OF THE COMPLAINT APPEARS TO BE RELATED TO PROCEDURAL ERROR. IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY A HEALTHCARE PROVIDER THAT A SURGEON ATTEMPTED TO EXPLANT AN INTERA 3000 HEPATIC ARTERY INFUSION PUMP AND REPLACE WITH ANOTHER PUMP. IT WAS REPORTED TO INTERA THAT IT WAS NOT A PUMP ISSUE AND THAT A RADIOLOGIST HAD "STRUCK" THE CATHETER CAUSING IT TO LEAK. THE CASE WAS ABORTED DURING THE REVISION, SO THE PUMP WAS EXPLANTED WITHOUT REPLACEMENT. IT WAS REITERATED TO INTERA THAT THAT THERE WAS "NOT AN ISSUE" WITH EITHER PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128532 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 28082047 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Hospitalization| R