MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO-MEDICUS NG 27 FR VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number 96670-127

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

Patient Problem Unspecified Infection (1930)

Event Date 09/08/2023

Event Type  Injury  

Manufacturer Narrative

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.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.

Event Description

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.

• Brand Name: BIO-MEDICUS NG 27 FR VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18109758
• MDR Text Key: 327883687
• Report Number: 2184009-2023-01038
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K142673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 96670-127
• Device Catalogue Number: 96670-127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• 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
• Patient Age: 60 YR
• Patient Sex: Male