BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA

    MDR report key: 22562228 · Received July 21, 2025

    Report

    Report Number
    3015537318-2025-00071
    Event Type
    Injury
    Date Received
    July 21, 2025
    Report Date
    July 21, 2025
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS INTERPRETED TO BE INTERA 3000 HEPATIC ARTERY INFUSION PUMP BASED ON THE TIME FRAME CITED IN THE STUDY. HEMATOMA IS A KNOWN ADVERSE EVENT ASSOCIATED WITH HEPATIC ARTERY INFUSION THERAPY AND IS LISTED ON THE LABELING OF THE INTERA 3000 IFU. BLANK INFORMATION IN THE MDR FORM REPRESENTS UNKNOWN INFORMATION AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    ADD PATIENT INFORMATION PROVIDED BY CORRESPONDING AUTHOR. INCIDENT DATE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    LITERATURE CITATION: LADONNA E KEARSE, COURTNEY DAY, ANDREA ZIRONDA, JESSICA MITCHELL, ZHAOHUI JIN, SUSANNE G WARNER AND CORNELIUS A THIELS, PROSPECTIVE EVALUATION OF THE QUALITY OF LIFE AND SAFETY IN PATIENTS RECEIVING HEPATIC ARTERY INFUSION PUMP CHEMOTHERAPY, SURGICAL ONCOLOGY INSIGHT, (2025) DOI: HTTPS://DOI.ORG/10.1016/J.SOI.2025.100159. LITERATURE CONTAINS A REPORT: "ONE PATIENT DEVELOPED A PUMP SITE HEMATOMA (CLAVIEN-DINDO GRADE 3B). THIS PATIENT UNDERWENT PUMP SITE HEMATOMA EVACUATION AND WASHOUT WITH SALVAGE OF THE HAI [HEPATIC ARTERY INFUSION] PUMP."

    Description of Event or Problem · 0

    LITERATURE CITATION: LADONNA E KEARSE, COURTNEY DAY, ANDREA ZIRONDA, JESSICA MITCHELL, ZHAOHUI JIN, SUSANNE G WARNER AND CORNELIUS A THIELS, PROSPECTIVE EVALUATION OF THE QUALITY OF LIFE AND SAFETY IN PATIENTS RECEIVING HEPATIC ARTERY INFUSION PUMP CHEMOTHERAPY, SURGICAL ONCOLOGY INSIGHT, (2025) DOI:HTTPS://DOI.ORG/10.1016/J.SOI.2025.100159. LITERATURE CONTAINS A REPORT: "ONE PATIENT DEVELOPED A PUMP SITE HEMATOMA (CLAVIEN-DINDO GRADE 3B). THIS PATIENT UNDERWENT PUMP SITE HEMATOMA EVACUATION AND WASHOUT WITH SALVAGE OF THE HAI [HEPATIC ARTERY INFUSION] PUMP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802121 INTERA HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 28894

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention