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

Model Number	96570-017
Medical Device Problem Codes	Fluid/Blood Leak (1250); Mechanical Problem (1384)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: 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
• Report Number: 2184009-2021-00123
• Device Sequence Number: 16592461
• Product Code: DWF
• UDI-Device Identifier: 00643169880771
• UDI-Public: 00643169880771
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K924642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 11/11/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 12/20/2021
• Date Device Manufactured: 11/11/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male