BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 20325476 · Received September 27, 2024

    Report

    Report Number
    3015537318-2024-00082
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    September 6, 2024
    Report Date
    September 27, 2024
    Manufacturer
    INTERA ONCOLOGY, INC
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR PUMP REVISION WAS THAT THE PUMP APPEARED THROUGH ABDOMINAL WALL. THERE WERE NO ISSUES WITH PUMP # (B)(6). TO DATE, THERE HAS BEEN NO ISSUES WITH NEW PUMP # (B)(6). THE DEVICE HISTORY RECORD, RTR-0883-20001 L/N 28557515, WAS REVIEWED. THERE WERE NO NONCONFORMANCES PERTAINING TO THIS SERIAL NUMBER. THERE WERE 1 DEVIATION RELATED TO THE MANUFACTURE OF THIS LOT. PUMPS THAT WERE STERILIZED AFTER THE ANNUAL STERILIZATION REQUALIFICATION TO BE MOVED TO QUARANTINE, RELEASED AFTER REQUALIFICATION WAS IMPLEMENTED. THE DEVIATION HAD NO IMPACT ON THE MANUFACTURE OF THIS LOT. THE DEVICE MET ALL SPECIFICATIONS PRIOR TO RELEASE FROM MANUFACTURING.

    Description of Event or Problem · 0

    INTERA ONCOLOGY RECEIVED A REPORT THAT PUMP WAS EXPLANTED FROM PATIENT ON (B)(6) 2024. ACCORDING TO THE PHYSICIAN, THE PUMP WAS EXTRACTED DUE TO PUMP APPEARING THROUGH ABDOMINAL WALL. THERE WERE NO REPORTED ISSUES WITH PUMP # (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1739832 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY, INC AP03000H 28803146 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other