MAUDE Adverse Event Report: UNKNOWN MEDIPORT CATHETER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Headache (1880); Nausea (1970); Vomiting (2144); Thrombosis/Thrombus (4440)

Event Date 06/09/2023

Event Type  Injury  

Event Description

Patient hospitalized on (b)(6) 2023 and treated for grade 3 enterocolitis, infectious w/neutropenia.Discharged (b)(6) 2023.Details about patient's hospital course will be entered via ctep-aers amendment#1 pending review of hospital records.(b)(6) 2023, amendment #1: the patient is a very pleasant 62 y.O.(year-old) female w/ pmh (past medical history) of htn (hypertension), dm (diabetes mellitus), stage ii (t3n0) adenocarcinoma of the transverse colon s/p partial colectomy ((b)(6) 2023).She is undergoing chemotherapy, on cycle 2 folfox trial gi-005, on 5/31 received 5fu bolus and oxaliplatin dose reduced due to nausea vomiting.She states she has been tolerating her treatment pretty well otherwise.She developed worsening nausea and vomiting for the past 3 days.She felt warm and chill yesterday and her temp was 99 f which is higher than her baseline.This morning she developed lower abdominal pain and diarrhea in total of 5-6 times (watery, non-bloody).She presented to oncology clinic earlier today (b)(6), received iv hydration.No bx of recent antibiotics.She reports she has had throbbing headache since she was diagnosed with thrombosis and her headache has been stable.In the ed 96/56-> 147/73, hr 107, rr 20, sat 97% ra, temp 37.4 c.Labs notable for neutropenia wbc 600, anc 60, na 132, k 2.7, blood culture taken.Her lactate is normal 1.2.Ct abdomen pelvis with contrast obtained which showed abnormal findings in mid to distal small bowel with wall thickening/mucosal enhancement, extending to small bowel splenic flexure anastomosis with surrounding mesenteric edema.She was given lr 1000 cc x2, empiric zosyn 4.5 gm iv, reglan 5 mg iv., kcl 10 meq x 2 doses, kcl 40 meq po.The patient was admitted with nausea, vomiting, abdominal pain and was found to have severe neutropenia secondary to chemotherapy.She was started on broad-spectrum antibiotics and was found to have bacteremia with multiple organisms likely of gi source.She was initially treated with zosyn and then transition to ertapenem based on sensitivities.She completed a 14-day course of antibiotics (2 days of zosyn then 12 of ertapenem).Given klebsiella had been zosyn resistant she will finish an additional 3 days of ciprofloxacin.General surgery was consulted however did not feel that surgical intervention was necessary.Repeat ct scan of her abdomen was obtained and suggested early abscess of enterocutaneous fistula.Both general surgery and colorectal surgery reviewed case.Colorectal felt findings were more consistent with enteritis and not ecf.General surgery continued to follow.Given clinical improvement in pain, leukocytosis they did not recommend follow-up ct scan unless clinical change.

• Brand Name: MEDIPORT CATHETER
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18987098
• MDR Text Key: 338796355
• Report Number: MW5153216
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/22/2024

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• Patient Sequence Number: 1
• Treatment: 5-FLUOROURACIL (5-FU), 4570MG.; LEUCOVORIN CALCIUM, 672MG.; OXALIPLATIN (ELOXATIN), 109 MG.
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 65 KG