BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 24987959 · Received April 24, 2026

    Report

    Report Number
    3015537318-2026-00034
    Event Type
    Injury
    Date Received
    April 24, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 22, 2026
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THIS DEVICE MET MANUFACTURING SPECIFICATIONS PRIOR TO DISTRIBUTION AND THERE WERE NO MANUFACTURING DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REGARDING THE ALLEGATION OF FAST FLOW, ELEVATED TEMPERATURES CAN CAUSE THE PUMP TO FLOW FAST. THE REPORTED ADVERSE EVENT IS RELATED TO PATIENT CONDITION. THE SCAN REVEALED THE PATIENT HAVING CHOLANGITIS AND WILL REQUIRE A STENT. IN ADDITION, THE PHYSICIAN CONFIRMED THAT THE ELEVATED LFT WAS NOT RELATED TO FLOXURIDINE.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A COMPLAINT REPORT THAT ON (B)(6) 2026, THE PUMP'S LATEST FLOW RATE WAS 1.7 AND THE RESIDUAL VOLUME WAS 6ML RESIDUAL. THE PATIENT HAD FEVERS IN PRIOR DAYS AND WAS ON ANTIBIOTIC DUE TO REDNESS AND DRAINAGE AT THE PUMP INFUSION SITE. ON (B)(6) 2026, THE PATIENT DID NOT RECEIVE FLOXURIDINE. THE CLINIC REMOVED 11.5 CC OF HEPARIN AND INFUSED 30ML OF HEPARIN BECAUSE IT DIDN'T WANT TO IRRITATE THE LIVER. IN ADDITION, THE CLINIC WAS WORRIED ABOUT CHOLANGITIS. THE PATIENT COMPLAINED OF HAVING NAUSEA AND ABDOMINAL PAIN. THE PATIENT'S ABDOMEN WAS DISTENDED. TAN/KHAKI COLORED STOOL WAS NOTED. THE PATIENT'S URINE COLOR WAS AMBER. THE PHYSICIAN PUT THE PATIENT ON CLEAR LIQUID DIET. THE PATIENT'S SKIN AND EYES WERE JAUNDICE. IN ADDITION, LIVER FUNCTION TEST (LFT) WAS ELEVATED, THE RESULTS WERE BILIRUBIN (BILI) OF 7, ALKALINE PHOSPHATASE (ALK PHOS) 757, ALANINE AMINOTRANSFERASE (ALT) 274, AND ASPARTATE AMINOTRANSFERASE (AST) 144. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM ON (B)(6) 2026, DUE TO THE PATIENT NOT EATING OR DRINKING. THE PATIENT HAD ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) DONE ON (B)(6) 2026, CT DONE ON (B)(6) 2026, AND MRI DONE ON (B)(6) 2026. THE HOSPITAL DID NOT PROVIDE US WITH THE RESULTS. HOWEVER, ACCORDING TO THE PHYSICIAN, THE SCAN REVEALED THE PATIENT HAVING CHOLANGITIS AND WILL REQUIRE A STENT. IN ADDITION, IT WAS CONFIRMED THAT THE ELEVATED LFT WAS NOT RELATED TO FLOXURIDINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430504 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP-03000H 30139907 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention