MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number DIALYSIS UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bradycardia (1751); Dyspnea (1816); Fever (1858); Unspecified Infection (1930); Chills (2191); Asystole (4442); Cough (4457); Respiratory Insufficiency (4462); Unintended Radiation Exposure (4565); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/26/2023

Event Type  Death  

Event Description

According to a literature case study, the patient was a 31 year old female who underwent simultaneous pancreas-kidney transplant in china nine years prior to the event.The patient had chronic renal graft dysfunction and received a permcath in 2018 to initiate regular dialysis treatment.The patient presented to the hospital with symptoms of fever, shortness of breath, shivering, and dry cough.Suspecting a central line infection, the patients immunosuppressive treatment was curtailed and antibiotic therapy was initiated (vancomycin, meropenem, and amikacin).On day seven the patient continued to have a fever and began to experience oxygen desaturation of 82-83% and was placed on a high flow nasal cannula.The patient was transferred to the intensive care unit (icu) for further treatment.In the icu the patient was transferred to a non-invasive continuous positive airway pressure (cpap).Additional cultures and labs were taken.A chest x-ray revealed bilateral extensive multi-lobar air space filling and ground glass opacities.While in the icu her hemodialysis continued.With a worsening chest x-ray and initial negative blood cultures the patient was started on a pneumocystis pneumonia protocol treatment and antibiotic therapy was discontinued.Sputum samples resulted in pneumocystis jirovecii.On day fifteen of admission the patient again began to deteriorate.Cultures were sent and antibiotic treatment was re-initiated.Blood cultures sent on day twelve resulted in the presence of yeast prompting the initiation of antifungal therapy.The patient continued to decompensate with increased tachypnea and the development of severe respiratory distress.The patient became unresponsive and was subsequently intubated and placed on mechanical ventilation.Within a few hours she developed bradycardia and asystole.Cardio pulmonary resuscitation (cpr) was initiated but was unsuccessful and the patient died on day fifteen of admission.The final result from the blood cultures came out positive for cryptococcus neoformans on day twenty, 5 days after patient death.

Manufacturer Narrative

Title: cryptococcemia in pancreas-kidney transplant patient source: medical mycology case reports 41 (2023) 41¿43 | available online 4 august 2023.H6 patient codes - e2402 (tachypnea).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DIALYSIS UNKNOWN
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18414680
• MDR Text Key: 331558209
• Report Number: 3009211636-2023-00371
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Reporter Country Code: TC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DIALYSIS UNKNOWN
• Device Catalogue Number: DIALYSIS UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Death; Hospitalization; Other
• Patient Age: 31 YR
• Patient Sex: Female