MAUDE Adverse Event Report: IV LINE; SET, ADMINISTRATION, INTRAVASCULAR

Patient Problems Bronchitis (1752); Cardiac Arrest (1762); Bone Fracture(s) (1870); Hemorrhage/Bleeding (1888); Necrosis (1971); Sepsis (2067)

Event Type  Injury  

Event Description

Pt's spouse reports pt had 1 bleed since their last hemlibra fill; no details available.Pt's spouse also reports pt went to er on (b)(6) 2023 for bronchitis, got unspecified breathing treatment and iv antibiotics.Within 1 minute after being given rocephin, pt went into cardiac arrest.Er md's think not necessarily reaction to rocephin because it was so immediate, instead may have been due to air bubble in pt's iv line.Pt had cpr for 6 minutes, got 4 broken ribs and was on a ventilator for 18 hours.Pt was given xyntha and then life flighted to (b)(6) where pt was hospitalized (b)(6) 2023 due to broken ribs from cpr and breathing concerns due to brochitis.Pt's spouse also reports pt went to a follow up appointment with their cardiologist on (b)(6) 2023; all known information is contained on this form.Consent to contact the reporter has not been received, for follow up please contact the prescriber.Onset/resolution dates/status of all reported symptoms/events unknown.Unknown if md aware of any/all events.Unknown if any events occurred on scheduled hemibra dosing days.No further info, details of dates available.Hemibrain and xyntha indications: hereditary factor viii deficiency, hereditary factor ix deficiency.Ritonavir, selzentry, isentress and darunavir indications: asymptomatic human immunodeficiency virus (hiv) infection.Pain in lower left abdomen towards their back.Pt's cardiologist told pt to go to er at (b)(6) as soon as possible, pt did and er blood work showed pt had sepsis.X-ray was negative so they did a ct scan without contrast which showed gas in lining of pt's colon, ct scan with contrast showed what the er md's thought was necrosis.Pt refused surgery and wanted second opinion, second set of surgeons said pt could try iv antibiotics; pt was given 3 different "pur" specified, antibiotics which did end up cleaning the infection.Pt was hospitalized (b)(6) 2023.Pt is still on 2 po antibiotics at home and is nearly done with course of treatment.Reported to (b)(6) by pt/caregiver.

• Brand Name: IV LINE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 17452615
• MDR Text Key: 320415638
• Report Number: MW5120537
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: DARUNAVIR 800MG; HEMLIBRA; ISENTRESS 400MG, MFR: MERCK SHARP & DOHME; RITONAVIR 100 MG, MFR: AUROBINDO PHARMA; ROCEPHIN; SELZENTRY 150 MG, MFR: "VIIV" HEALTHCARE
• Patient Outcome(s): Hospitalization
• Patient Sex: Male