MAUDE Adverse Event Report: SRBT

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Fever (1858); Tachycardia (2095); Chills (2191); Choking (2464); Increased Respiratory Rate (2486)

Event Date 02/09/2015

Event Type  Injury  

Event Description

Additional information received from rptr on (b)(6) 2015.Patient met sirs criteria for sepsis and was started on board spectrum antibiotics for presumed mcap as well as prednisone and inhalers for copd exacerbation.Patient initially was treated with vancomycin, cefepime and azithromycin.Patient tested positive for rhinovirus/enterovirus and on (b)(6) 2015 patient was switched to a 14 day course of levaquin.Patient was discharged on (b)(6) 2015.Dyspnea on admission - grade 4 (max) related to infectious process, grade 2 at discharge.Tachycardia on admission - grade 2 related to infectious process (resolved).Fever on admission - grade 1 related to infectious process (resolved).Cough on admission - grade 1 related to infectious process, continues at discharge.Hypomagnesemia at admission - grade 1 (max) possibly related to prior chemo/infectious process (resolved).Acute kidney injury at admission - grade 1 possibly related to infectious process (resolved).Increased creatinine at admission - grade 1 possibly related to infectious process (resolved).Nausea on admission - grade 1 (max) possibly related to infectious process (resolved).Dizziness at admission - grade 1 possibly related to infectious process (resolved).Hypoxia at admission - does not meet gradeable criteria of 88% or less, possibly related to infectious process (resolved).Leukocytosis at admission - grade 3 related to infectious process (resolved) suspected sepsis at admission - grade 4 based on sirs criteria of tachycardia and leukocytosis (resolved).Upper respiratory infection (pneumonia) - grade 3 related to positive rhinovirus/enterovirus, not considered resolved until course of antibiotics completed.Per (b)(6) all above unlikely related to sbrt, relatedness provided for each.

Event Description

Patient was enrolled into the (b)(6) study on (b)(6) 2014.Sbrt was given on (b)(6) 2014, patient received a total of 2800cgy.On (b)(6) 2015 patient presented via ems to treating hospital's ed with worsening dyspnea.On arrival by ems patient's oxygenation was 90% and recovered to 99% with cpap and was given albuterol treatment prior to arriving at ed.Patient was noted to have a productive cough and fever 101.5 on arrival.Patient was tachycardic and tachypneic and was switched to bipap.Ct scan of chest was negative for pulmonary embolus but was suspicious for multifocal pneumonia and patient was admitted to treatment and further evaluation.Dyspnea at admission-grade 4.Tachycardia at admission-grade 2 (resolved).Fever at admission-grade 1 (resolved).Cough at admission-grade 1.Per (b)(6) all above are unlikely related to srbt but likely viral in nature.Further information will be provided when available.Dose, frequency and route used: #1: 1400cgy; #2 1400cgy.Therapy dates : #1: (b)(6) 2014.Diagnosis for use: squamous cell carcinoma, lung.

Event Description

Additional information received (b)(6) 2015: new information from admission and follow-up: patient reported 1 episode of near choking while eating on day prior to admission which prompted a nbs to be done during admission which showed high risk for aspiration and patient's diet was modified.Along with patient's previous positive rvp for rhinovirus, patient tested positive for influenza a at this admission.The patient experienced the following symptoms secondary to infection (influenza/pneumonia/lung infection); fever, chills, tachycardia, cough and dyspnea.The patient was treated for these events and discharged on (b)(6) 2015.Lung infection/pneumonia/uri - grade 3 unlikely related to sbrt.Influenza a (infection other) - grade 3 unlikely related to sbrt.

Event Description

Additional information received from rptr on (b)(4) 2015.On (b)(6) 2015, patient presented via ems to treating hospital's e.D.With fever, chills, shortness of breath and productive cough.Patient had been previously admitted for similar symptoms on (b)(6) 2015 and was discharged home on (b)(6) 2015.On this presentation chest x-ray showed worsening right lung opacities but improved left lung with concern for aspiration pneumonia.At arrival patient's temp was 102.8 and patient was tachycardiac at 123 bpm which meets sirs criteria for sepsis and patient was started empirically on broad spectrum antibiotics.Along with patient's previous positive rvp, patient tested positive for influenza a at this admission.Fever at admission - grade 3.Aki at admission - grade 1.Dyspnea at admission - grade 3.Uri/copd exacerbation at admission - grade 3.Lung infection/influenza a/hcap at admission -grade 3.Chills at admission - grade 1.Productive cough at admission - grade 1.All listed grade adverse events not related to srbt but related to viral/infectious process.Further information will be provided when available.

• Brand Name: SRBT
• Type of Device: SRBT
• MDR Report Key: 4528254
• MDR Text Key: 5347599
• Report Number: MW5040764
• Device Sequence Number: 1
• Product Code: IYE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/24/2015; 02/27/2015; 03/06/2015
• Patient Sequence Number: 1
• Treatment: GLYBURIDE; ALBUTEROL; CALCIUM; OMEPRAZOLE; SINGULAIR; LOSARTAN; LIPITOR; PREDNISONE; AZATHIOPRINE; MESTINON; MVI; ADVAIR DISKUS; ASPRIN EC
• Patient Outcome(s): Hospitalization
• Patient Age: 76 YR