MAUDE Adverse Event Report: PERFUSION SYSTEMS EOPA 3D VENTED ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 78220

Device Problem Positioning Failure (1158)

Patient Problems Hypovolemia (2243); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Event date was requested but unknown.Model number 78220 was chosen as a placeholder for the cannula model.The customer stated they did not know the model <(>&<)> lot number of the arterial cannula used.And that the device was discarded following use.Device was discarded by the customer.Investigation conclusion: medtronic cannot confirm or deny the complaint of an attachment issue with the arterial cannula, as no photo has been provided and no product has been returned.A root cause of this occurrence cannot be determined without returned product.The device history record could not be reviewed as no lot number was provided.There were no trends warranting escalation related to this occurrence.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the customer reported an attachment issue with the arterial cannula.When checking the positioning of the arterial cannula, there was dehydration, causing hemorrhage.According to the surgeon, the absence of a fixation surface on the cannula contributed to the incident.The product was used to complete the case.Plasma and red blood cell transfusions were administered for hypovolemia.The patient was discharged in good condition, returning on the scheduled day for re-evaluation, without any adverse impact.

Manufacturer Narrative

Following corrections included as part of supplemental report: (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use, the customer reported an attachment issue with the arterial cannula.When checking the positioning of the arterial cannula, there was dehydration, causing hemorrhage.According to the surgeon, the absence of a fixation surface on the cannula contributed to the incident.The product was used to complete the case.Plasma and red blood cell transfusions were required due to hypovolemia.The patient was discharged in good condition, returning on the day scheduled for re-evaluation, without any adverse impact.The following transfusions were made: 3 pockets of fresh plasma (590 ml).The day after the incident, an additional 2 bags of packed red blood cells (569 ml) were administered.

• Brand Name: EOPA 3D VENTED ARTERIAL CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8694676
• MDR Text Key: 147849091
• Report Number: 2184009-2019-00040
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K150422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

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: No Information
• Device Model Number: 78220
• Device Catalogue Number: 78220
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 06/13/2019
• Supplement Dates Manufacturer Received: 05/20/2019
• Supplement Dates FDA Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 7 YR
• Patient Weight: 39