MAUDE Adverse Event Report: PERFUSION SYSTEMS PEDIATRIC BIOMEDICUS FEMORAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number 96820-014

Device Problems Break (1069); Air/Gas in Device (4062)

Patient Problems Hemorrhage/Bleeding (1888); Brain Injury (2219)

Event Date 04/01/2024

Event Type  Injury  

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.

Event Description

Medtronic received information that during use of a pediatric bio-medicus femoral cannula, it was reported that the device broke.The device was used to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the cannula was not heated or cooled prior to use.There was no damage to the packaging (outer box, inner packaging or sterile barrier).No other devices in the same box/shipping container also damaged.There was patient blood loss as a result of this breakage.A transfusion was not required as a result of this.Medtronic received additional information that after the cannula was inserted, air was detected in the extracorporeal membrane oxygenation (ecmo) equipment, causing it to stop functioning.Upon removing the cannula after treatment, it was confirmed that the cannula was broken.The broken part was lightly touched by hand after confirming the breakage of the cannula, but it is suspected that air entered the patient's brain due to the incomplete connection of that part.Currently, the patient has recovered normally from ecmo, but has suffered brain damage.Medtronic received additional information that upon further inspection revealed that the broken section of the cannula was identifiable, and upon gentle manipulation, it was apparent that the fracture extended beyond what was initially noticed.

Manufacturer Narrative

Device evaluation summary: visual inspection shows evidence of damage/split.Reason for return was confirmed.Medtronic received additional information that the device was in use for 1-1.5hrs.The clamp was used in the upper site of the broken section.Air was detected in the ecmo equipment, leading to ecmo operation cessation.Medtronic received additional information that the customer clamped the upper area where the leakage was expected and subsequently removed the cannula.The patient continues to receive ongoing treatment.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.

• Brand Name: PEDIATRIC BIOMEDICUS FEMORAL 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: 19141774
• MDR Text Key: 340566531
• Report Number: 2184009-2024-00199
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K872033
• 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,Followup
• Report Date: 05/14/2024

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: 96820-014
• Device Catalogue Number: 96820-014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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): Life Threatening