BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEXION X1

    MDR report key: 13011492 · Received December 15, 2021

    Report

    Report Number
    3011716550-2021-00002
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    November 17, 2021
    Report Date
    November 17, 2021
    Manufacturer
    REFLEXION MEDICAL, INC.
    Product Code
    MUJ
    UDI-DI
    00860003983805
    PMA / PMN Number
    K190978
    Removal / Correction Number
    3011716550-12/9/21-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFLEXION HAS INVESTIGATED THE ISSUE AND DETERMINED THE CAUSE TO BE A CODE IMPLEMENTATION DEFECT IN THE TREATMENT PLANNING SOFTWARE. WHEN REFLEXION'S TREATMENT PLANNING SYSTEM CALCULATES DOSE, AN ACCURATE ORIENTATION FOR IMAGE, DOSE, PRIMARY BEAM, AND SCATTER ORIENTATION (DOSE ANGLES) IS NECESSARY. THE SCATTER ORIENTATION IN THE DOSE CALCULATION ALGORITHM IS INCORRECT FOR ANY PATIENT ORIENTATION OTHER THAN HEAD FIRST SUPINE (HFS). THE OTHER PATIENT ORIENTATIONS ARE HEAD FIRST PRONE (HFP), FEET FIRST PRONE (FFP), AND FEET FIRST SUPINE (FFS). TREATMENT PLANS FOR HFS ARE NOT AFFECTED.

    Description of Event or Problem · 0

    PATIENT (B)(6) RECEIVED 15 OUT OF 25 PLANNED FRACTIONS FOR PROSTATE BED + LYMPH NODE ON THE REFLEXION X1 SYSTEM. DURING THE INITIAL 15 FRACTIONS ON X1, THE PATIENT RECEIVED AN OVERDOSE OF 9.6% TO THE PLANNING TARGET VOLUME (PTV) DUE TO A DEFECT IN THE TREATMENT PLANNING SOFTWARE DOSE CALCULATION. AFTER THE ISSUE WAS IDENTIFIED, HE RECEIVED THE REST OF HIS TREATMENT ON ANOTHER RADIOTHERAPY DEVICE, WITH THE TREATING RADIATION ONCOLOGIST DECIDING TO DROP SOME OF THE REMAINING FRACTIONS TO COMPENSATE. THE ACTUAL FINAL DELIVERED PRESCRIPTION DOSE AMOUNTED TO A 1.25% UNDERDOSE, WHICH STILL MEETS CLINICAL TREATMENT GOALS. THE FINAL, AGGREGATE DELIVERED DOSE TO ALL ORGANS AT RISK STILL FELL WITHIN ACCEPTABLE TOLERANCE DOSE LIMITS. THERE IS NO EXPECTATION THAT THE FINAL DOSE DISTRIBUTION WOULD CAUSE EXCESS RISK OF HARM BEYOND THE BASELINE LEVEL OF RISK OF PROSTATE BED RADIOTHERAPY. ADDITIONALLY, THE INCREASE IN THE RISK OF SECONDARY MALIGNANCY IS MINIMAL IN THIS SCENARIO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905345 REFLEXION X1 REFLEXION MEDICAL RADIOTHERAPY SYSTEM MUJ REFLEXION MEDICAL, INC. RXM1000 NA 00860003983805

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose