MAUDE Adverse Event Report: MEDTRONIC MEXICO AFFINITY CP CENTRIFUGAL PUMP; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	CBAP40
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Noise, Audible (3273)
Health Effect - Clinical Codes	Bradycardia (1751); Low Oxygen Saturation (2477)
Date of Event	03/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Note: per the device indications for use the affinity cp centrifugal blood pump is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours).It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (eg, valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of the cbap40 centrifugal blood pump in the vv-ecmo circuit, the pump needed to be changed out after running for 7-days ((b)(6) 2020).The healthcare professional (hcp) was in house monitoring his patient on ecmo when the nurse in the patient's room called him because she started to hear a distinct noise coming from the pump.When the hcp returned to the icu room, the pump was making a significant loud grinding noise, as if it was going to decouple.Pump flow was also reduced and the patient sat's were dropping to the 70s and his heart rate was beginning to brady due to reduced flow from the noisy pump.He clamped off the circuit, pulled the pump off and reseated it.He restarted the pump and it flowed ok until they got above 4.0lpm.He tried to get back to full flow, which was above 4.0lpm, but could not because the noise retuned.The noise returned when flows reached above 4.0lpm.Normal flow for patient was 4.5-5.0lpm, which they could not achieve without the pump making noise.The hcp then decided to change out the motor drive to see if that would resolve the issue, but it did not resolve the noise.He also clamped the circuit off a second time to try to reseat the pump, but it again started making noise above 4.0lpm.The hcp was concerned about the pump eventually decoupling, that per the way it was functioning and making noise.It was decided by the perfusion team to change the pump and replace it with a new one.The patient was off vv-ecmo for about 2-3 minutes during change out.Once the new pump was in, they restarted flow and there were no issues.No noises or flow problems with the new cbap40.Patient did fine with the change out and was stable.

• Brand Name: AFFINITY CP CENTRIFUGAL PUMP
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• MDR Report Key: 9896813
• Report Number: 2184009-2020-00021
• Device Sequence Number: 2827327
• Product Code: DWE
• UDI-Device Identifier: 00763000074418
• UDI-Public: 00763000074418
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K132712
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2020

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: 07/03/2021
• Device Model Number: CBAP40
• Device Catalogue Number: CBAP40
• Device Lot Number: 218026105
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 29 YR
• Patient Weight: 130