MAUDE Adverse Event Report: MRI MACHINE; SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cardiac Arrest (1762); Fever (1858); Inflammation (1932); Pain (1994); Paralysis (1997); Skin Discoloration (2074); Shaking/Tremors (2515); Partial thickness (Second Degree) Burn (2694)

Event Date 03/09/2021

Event Type  Death  

Event Description

My(b)(6) year old son's teeth, hands, lips, legs were burned during an mri.Neck muscles were damaged.My husband and i drove my son from (b)(6) to see a licenced physician who examined my son and provided me with letters recommending that my son is no longer treated with mris with contrast or without contrast, in order to prevent any flare up reactions.However, on (b)(6) 2021 during my sons routine oncologist appointment at (b)(6), my son was admitted into the hospital.My son had a covid-19 test on (b)(6) 2021 prior to being admitted to (b)(6).While we were waiting for the covid-19 results, a floor doctor from (b)(6) examined my son and determined that my sons eyes were not dilating.However, three (3) months prior my sons eyes were already not dilating and (b)(6) documented this detail in my sons medical chart.The floor doctor didn't bother to look at my sons medical chart from a previous admission were it clearly stated that his eyes were not dilating.Instead, the floor doctor ordered an mri.I immediately declined the mri citing letters that i had from the licenced physician warning that my son has negative side effects following such mris.The floor doctor ended up putting in the order for the mri with no contrast and a feeding tube.The mri lasted 7 minutes.When my son came out the mri, he had a fever and was shaking non- stop, additionally his 2 legs looked very dark.(he did not go in there with really dark legs).As a nurse took my son and i back to a room, my son was given a formula for his feeding tube that only made his fever go up even higher and the shaking worsened.My son was in so much pain then his knees were swollen.I informed the doctor to remove the feeding tube, which he did and about three (3) hours later the fever and shaking stopped.The following day doctors came in advising me that they needed a 2-3 hour mri for my son in order to get a better look of his brain.Once again i declined the mri citing the letters i had and warning of how my son has negative side effects (fever, body shaking and inflammation) to mris.I also showed them my sons urine test results demonstrating heavy metals in his urine.My sons urine results are extremely high for gadolinium as well.Unfortunately, not one doctor listened or cared for what i was presenting.I declined the 2 hour mri and as a result, (b)(6) called child protective services on me.On (b)(6) 2021, my son went into the mri machine once again.My son coded during the mri.When my son came out, his hands, legs, lips and teeth were burned.Physicians and nurses acted as if nothing was happening.Additionally my son lost all movement to his right arm and eye immediately after the mri on (b)(6) 2021.My son was put in the picu after the mri.An ultrasound of my sons heart was conducted immediately after the mri.As if my sons heart looked as if it was going to pop out his chest.My son was not able to fold his left arm anymore immediately after the mri, he developed severe mast cell activation syndrome after the mri.On (b)(6) 2021 a toxicologist from (b)(6) came into examine my son recommending yet another mri with contrast.I told him to leave the room.My son is dead.He died on (b)(6) 2021 additionally my son lost all muscles movement to his neck.My son was sedated during this procedure.Fda safety report id# (b)(4).

• Brand Name: MRI MACHINE
• Type of Device: SYSTEM, NUCLEAR MAGNETIC RESONANCE IMAGING
• MDR Report Key: 12546715
• MDR Text Key: 273798445
• Report Number: MW5104248
• Device Sequence Number: 2
• Product Code: LNH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 09/24/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Disability
• Patient Age: 5 YR
• Patient Weight: 15