BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERA 3000

    MDR report key: 20533093 · Received October 25, 2024

    Report

    Report Number
    3015537318-2024-00090
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    September 30, 2024
    Report Date
    October 25, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD, RTR-0883-20001 L/N: 28679, WAS REVIEWED. THERE WERE NO NONCONFORMANCE'S PERTAINING TO THIS SERIAL NUMBER. THE DEVICE MET ALL SPECIFICATIONS PRIOR TO RELEASE FROM MANUFACTURING. DURING FOLLOW-UP ON (B)(6) 2024, THE NURSE STATED THE PATIENT SWITCHED BACK OVER TO HEPARIN EVERY 14 DAYS. THE PATIENT IS GOING TO GO FOR A PUMP FLOW STUDY. INTERA ONCOLOGY IS PRESENTLY INVESTIGATING THE ROOT CAUSE OF THE REPORTED INCIDENT AND IS IN COMMUNICATIONS WITH THE CLINIC ABOUT THE RESULTS OF THE PUMP'S FLOW STUDY TESTS. THE CAUSES OF THIS INCIDENT ARE INCONCLUSIVE. THEREFORE, ONCE WE OBTAIN UPDATED INFORMATION, WE'LL SUBMIT A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    INTERA ONCOLOGY, RECEIVED A REPORT FROM A PHYSICIAN THAT A PATIENT'S INTERA 3000 PUMP HAS BEEN RETURNING CLOSE TO 30 MLS EVERY 6 WEEKS. THE CLINIC ORIGINALLY DISPENSED 30ML OF GLYCERIN TO THE PUMP. THE MEDICAL ONCOLOGIST HAS SWITCHED PATIENT BACK TO HEP SALINE TO ENSURE THAT THE PUMP IS STILL FUNCTIONING NORMAL. THE CLINIC ASSURED INTERA ONCOLOGY THAT THEY RINSED THE PUMPED WITH 2 30ML SYRINGES OF SALINE BEFORE REFILLING WITH HIGH DOSE HEP SALINE (1000 UNITS/ML). THEY ALSO FLUSHED THE CATHETER USING OUR SBN AND 3MLS OF SALINE. DESPITE FOLLOWING THE CORRECT PROCEDURE, THEY SAID IT IS STILL FLOWING VERY SLOW, ONE OF THE NURSES STATED THE PUMP RETURN 28CCS, INTERA ONCOLOGY IS UNSURE IF THIS WAS BEFORE OR AFTER SWITCHING THE PATIENT TO HIGH DOSE HEP SALINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047277 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 28787 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male