MAUDE Adverse Event Report: ENDOTRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Device Problems No Audible Alarm (1019); Leak/Splash (1354); Loose or Intermittent Connection (1371); Material Puncture/Hole (1504); Pressure Problem (3012)

Patient Problems Headache (1880); Liver Damage/Dysfunction (1954); Muscle Weakness (1967); Nausea (1970); Pulmonary Edema (2020); Jaundice (2187); Anaphylactoid (2218); Low Oxygen Saturation (2477); Diminished Pulse Pressure (2606); Weight Changes (2607); Hallucination (4428); Thrombosis/Thrombus (4440); Epistaxis (4458); Renal Impairment (4499); Decreased Appetite (4569); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/11/2019

Event Type  Death  

Event Description

My husband died i believe of medication interactions and i was wondering if the physician or pharmacy should have at least gotten something on the computer that alerted them of these drugs.My husband had stage 4 lung cancer in 2009 and he went through a clinical study which miraculous killed the cancer in 2011 per his last pet scan and his oncologist.In 2017 (b)(6) started having breathing issues and was given medication for the cough and breathing issues albuterol sulfate, prednisone 10 mg, amlodipine besylate 10mg and mucinex which these were discontinued in 2018 as he was placed on trelegy.In 2018 (b)(6) was once again diagnosed with stage 4 lung cancer and was put on chemotherapy and keytruda but he started developing fluid between his lungs and chest wall he had a chest tube procedure in (b)(6) 2019.His oncologist changed his pain medication from hydrocodone to tramadol hcl 50 mg.(b)(6) appetite started going down and started having weakness, so the doctor prescribed megestrol acetate 10 ml x 1 day.(b)(6) was given a new oncologist due to his other leaving the practice.This new oncologist changed his medications to mirtazapine (15 mg x 1 day for 2 wks then increased to 30 mg 1 day) as the megestrol acetate caused him blood clots per ct scan, tramadol was increased to 100 mg every 6 hours, alprazolam 1 mg x 2-day, lorazepam, ondansetron (b)(6) started having nose bleeds, hallucinating, weight loss, white spots on his tongue and was very weak, he was nauseated, headaches and agitation and loss of muscle mass.On (b)(6) 2019 informed the home health his chest tubes stitch was loose and that he was not his self (they told us about remeron and side effects).The home health did a well check and noticed his eyes were jaundiced, she informed his pulmonologist of this issue and requested him go to the er.(b)(6) was seen and the nurses went over his medication list (at least we thought they did, they did not update his medication and used an old medication list from 2 years prior) i told the nurse he was not on amlodipine besylate as he had low blood pressure and it was discontinued in (b)(6) 2018.I also told the staff that (b)(6) started getting these symptoms when he started mirtazapine, ultram, ondansetron, lorazepam and alprazolam he was admitted but it took 2 days to get to the medical floor as his liver enzyme was 2.2 (b)(6) did not make it too long as they continued to give him these medications and would not listen to me about the new medication mirtazapine 30 mg after that last does and increase of amlodipine and lorazepam,tr they called rapid response placed him on bipap gave phenylephrine hcl 25 1x1;000 mg iv drip to keep map (mean arterial pressure) 65, which he was failing as he could not breathe, o2 sats (oxygen saturation) dropped to 40%.Two days later they found him unresponsive, no blood pressure, no pulse and eyes were dilated and had another code they had to intubate x 2 due to hole in first one they discontinued mirtazapine.The doctor did not follow his critical labs they were extremely high, and his blood platelets went from 233 to 33 liver and kidneys were failing, he could not eat or drink, his feet started turning purple and the doctor ordered and put capsaicin cream (cayenne pepper as i know now) on his feet he went into anaphylactic hands, legs body flying up and down in bed basically seizure.(b)(6) died a horrible death on (b)(6) 2019.Medication given were, lorazepam 1 mg iv push x 2, alprazolam 2 mg tablets x day, ondansetron hcl 4 mg iv, ultram 100 mg tablet every 6 hours, mirtazapine 30 mg for appetite amlodipine besylate 10 mg 1 day (b)(6) 2019 - (b)(6) 2019, albuterol solution 3 ml as needed, folic acid, ferrous sulfate 325 mg x 1 dextromethorphan-guaifenesin x release every 12 hrs potassium chloride 20 meq per acetaminophen 2x500 every 6 hrs, probiotic 2x 50bc a day, oxymetazoline hcl spray 0.05% every 12hr, apixaban 5 mg x 2 day (b)(6) 2019-(b)(6) 2019), prednisone 20 mg x 2 a day, phytonadione 5 mg injection, hydromorphone 1 mg in leg muscle.I was wondering how a doctor, the only pharmacist that you go to, the er doctors, the hospital where the doctor who prescribed your medications can miss medication interactions.Yes, i asked the pharmacy if there would be any interactions and they said no.This is the same pharmacy who said i would not have any interactions with my diabetes medication (sitagliptin) and hydrochlorothiazide.I ended up admitted to the hospital.Was not happy as i also had critical low potassium (2.1) and magnesium.They said they are not responsible to check medication interactions it is up to the doctor.I also had a meeting with the head pharmacist, and they said they probably just bypassed the black box.So if we can't trust our doctors, pharmacist who can we trust in deadly medication interactions.As for (b)(6) found unresponsive the monitor alarms did not go off in the room or hospital.The nurse came by at 5 am talking to him did not get a response opened his eyes looked at the monitor and said it did not go off and his eyes were dilated and blood pressure cuff had a leak in it.And as i stated we only use one pharmacy besides the (b)(6) 2019.Fda safety report id# (b)(4).

Event Description

Additional information received from a reporter on 7/24/2022 for report number mw5110872.More information on previous report (b)(4).During awake intubation no etomidate was used patient was in severe acute respiratory failure and unresponsive(no blood press nor pulse)patient started bleeding from the mouth and producing bloody sputum from his et tube.0630 on (b)(6) 2019 after tube was placed.The doctors did not recognized where the blood was coming from.Patient's blood platelets were dropping.During a mouth cleaning by nurse that evening nurse found a tooth(root and all) dislodged in patients mouth.Tooth given to patient's wife.During the next early morning of (b)(6) 2019 patient was not getting enough volume and ett tube was failing patient was gagging and choking.Nurse called for assistance and patient was then intubated again and was given 20 mg etomidate and a 8.0 was used also a bougie.The nurse said there was a hole in the cuff and was leaking.Patient icu monitor was not alarming off in room nor in hospital an arterial line was introduced into the femoral artery due to monitor not working correctly throughout his stay (b)(6) 2019-(b)(6) 2019.Picture already sent in previous emails.Also hospital said they notified the fda on capsaicin cream interactions.Will add more.(b)(4).

• Brand Name: ENDOTRACHEAL TUBE
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• MDR Report Key: 15027694
• MDR Text Key: 296054177
• Report Number: MW5110872
• Device Sequence Number: 4
• Product Code: MHX
• Combination Product (y/n): N
• 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,Followup
• Report Date: 07/24/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/29/2022
• Patient Sequence Number: 1
• Treatment: ALBUTEROL SULFATE; ALPRAZOLAM; AMLODIPINE BESYLATE; BIPAP; CAPSAICIN CREAM; CHEST TUBE ; ETOMIDATE; HYDROCODONE; KEYTRUDA; LORAZEPAM; MEGESTROL ACETATE; MIRTAZAPINE; MUCINEX; ONDANSETRON ; PREDNISONE ; TRAMADOL HCL; TRELEGY ELLIPTA
• Patient Outcome(s): Hospitalization; Death; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American