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

Model Number 96570-017

Device Problems Fluid/Blood Leak (1250); Mechanical Problem (1384)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/16/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the use of a bio-medicus cannula, the customer reported that whilst changing the position of the patient, the nurse observed massive bleeding from the ecmo cannula insertion site, located in the right jugular region.The customer reported that it was due to accidental removal of the device, resulting in hemodynamic instability.The customer has reported that the bleeding was controlled with direct compression, they then proceeded to perform neuromuscular blockade, sedoanalgesia adjustment, re-cannulated with all ecmo equipment circuit and membrane change.The patient was transfused 2ugr and 1 plateletpheresis, vasoactive titration and sedoanalgesia.The patient status is critically ill patient and continuing ecmo therapy and vmi.Additional information: the patient had been hospitalized in icu with pneumonia severe virus due to sars-cov2, hypoxemia, and need for ventilation mechanical, on ecmo therapy since (b)(6) 2021.

• Brand Name: BIO-MEDICUS 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13044261
• MDR Text Key: 284387457
• Report Number: 2184009-2021-00123
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00643169880771
• UDI-Public: 00643169880771
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K924642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 96570-017
• Device Catalogue Number: 96570-017
• Device Lot Number: 2020110564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/20/2021
• Date Device Manufactured: 11/11/2020
• 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: 46 YR
• Patient Sex: Male