PERFUSION SYSTEMS BIO-MEDICUS NG ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
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Model Number 96570-121 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 09/08/2023 |
Event Type
Injury
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Event Description
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Medtronic received information via a literature case report regarding a the use of hepatic support with molecular absorbent recirculation system (mars) in treatment with extracorporeal membrane oxygenation (ecmo) and continuous renal replacement therapy (crrt) therapies.The patient was admitted for pneumonia secondary to sars-cov-2 with severe acute respiratory distress syndrome (ards).The ecmo cannulation was via a right femoral-internal jugular access, and with a rotaflo centrifugal pump.A medtronic 21 fr jugular cannula and 27 fr femoral cannula were used for veno-venous ecmo.It was reported that during the hospital stay, the patient developed several infections, including klebsiella pneumoniae in the blood culture and candida auris in the aerobic blood culture drawn from the ecmo and power-picc catheter.Multiple antibiotics were used such as ceftaroline, imipenem, linezolid, trimethoprim/sulfamethoxazole, anidulafungin, meropenem, ceftazidime, liposomal amphotericin b, and levofloxacin.Also, the ecmo cannulas were replaced completely, including the ecmo circuit; placing the cannulas in the same position as the previous ones.Based on the available information, these infections may have been attributed to medtronic product.Several other complications were reported, including; ventricular tachycardia, gastrointestinal bleeding due to peptic ulcer, alveolar hemorrhage, hemothorax, septic shock, and patient death 2 months after the start of treatment.However, based on the available information, none of these adverse events were attributed to medtronic product.No additional adverse patient effects or product performance issues were reported.
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Manufacturer Narrative
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Literature details: title: use of hepatic support with mars in a patient with sars-cov-2 pneumonia, in treatment with ecmo and crrt therapies: case report.Authors: villarreal-ondarzai, rodríguez-salinasc, gómez-gutierrezr, guerrero-izaguirrei, rizo-topetel journal: j extra corpor technol 2023, 55, 130¿133 doi: 10.1051/ject/2023025.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.
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