MAUDE Adverse Event Report: MEDTRONIC MEXICO BIO-MEDICUS LIFE SUPPORT TM; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	LS96555-019
Medical Device Problem Codes	Fracture (1260); Material Puncture/Hole (1504); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that at an unspecified time, this bio-medicus life support cannula had fractured at the connection site from the extra corporeal membrane oxygenation (ecmo) cannula (3/8¿ connector) to the circuit.The customer stated that the connector wall of this cannula appears very thin.The fracture was noticed in time.The device was replaced. there was no adverse patient effect reported with this event.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
E.Initial reporter: first name, last name, phone number and email: these fields were updated.H6.1 device codes (fdd/annex a): this field was updated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction e1: initial reported updated, based on clarification received.Additional information received shows that this event is a duplicate of the event reported under mdr #9612164-2024-02765.It was confirmed that the customer had internal communication problems, and the complaint was submitted twice in error.This duplicate record will be closed as a non-complaint, as all relevant information was previously captured in#9612164-2024-02765.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: BIO-MEDICUS LIFE SUPPORT TM
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19653774
• Report Number: 9612164-2024-03062
• Device Sequence Number: 6549680
• Product Code: DWF
• UDI-Device Identifier: 00763000615499
• UDI-Public: 00763000615499
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K201057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2026
• Device Model Number: LS96555-019
• Device Catalogue Number: LS96555-019
• Device Lot Number: 227145850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 07/08/2024; 09/16/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/06/2024; 10/02/2024
• Date Device Manufactured: 08/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown