MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY CP CENTRIFUGAL BLOOD PUMP; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number AP40

Device Problems Obstruction of Flow (2423); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Medtronic received information that during use of an affinity cp centrifugal blood pump, the customer reported that after 10 days in use, the pump started to make a new buzzing/vibration noise.The noise was coming from the pump cone or the external drive.The physician could not determine which of the two components were the source of the noise as both were vibrating together.After approximately 4 minutes the vibration/buzzing noise greatly increased.The rpms on the console did not change.The flows rapidly decreased and the patient's saturations dropped immediately.By that time, the physician, nursing and respiratory therapy staff were at the bedside.They began running a code as the patient's pressure rapidly decreased and they became bradycardic.The nurse clamped both drainage and return extracorporeal membrane oxygenation (ecmo) circuit lines and the physician stopped the pump drive, removed the cone from the drive and removed the tubing from the cone by hand.They then connected one port of the new cone to the circuit tubing and primed the new cone with the patient's volume.When the cone was ready they completed the circuit connection and placed the new cone in the drive.The process of removing the old cone and priming and connecting the new cone took approximately 3 minutes.The physician restarted the pump with the new cone.The vibration and buzzing sound was gone and flows were brought up to previously levels quickly (6.2 lpm, 3230 rpm).The patient was successfully resuscitated.Additional information was received indicating that a second ap40 centrifugal pump failed 13 days after the first pump had failed.The perfusionist was sitting near the patient and heard a grinding sound.The perfusionist came around immediately and placed their hand on the pump and ap40 centrifugal pump to determine if it was mechanical or disposable.While they was there the centrifugal pump failed completely.The perfusionist was aware of the previous issue since previous perfusionist had let him know of the earlier failure when the current perfusionist arrived as a locum.The current perfusionist had a spare centrifugal pump and supplies available on the heater so everything was at hand.By the time the current perfusionist called for respiratory staff and nursing help and they returned to the bedside, the current perfusionist had ripped off the old centrifugal pump and had a new centrifugal pump partially primed.The perfusionist stated that the patient was off support for approximately 2 minutes.The patient did not decompensate as much as the first time since the patient had a bit of reserve at this point.

Manufacturer Narrative

Conclusion: the complaint was not confirmed for the pump making a grinding sound and failing.The device was not returned for analysis.The root cause of the issue could not be determined.Review of the complaint file determined that the device was used for greater than six hours.This is off-label use because per the indications for use (ifu), "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 (e.G., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants)." additionally, the case record was provided.The case record was reviewed with a medtronic medical affairs representative.While the pump was in use, from (b)(6) 2021, low anti-xa measurements, instances of heparin being shut off before and after tracheotomy, and clots in the extra-corporeal membrane oxygenation (ecmo) circuit oxygenator were reco rded.This is off-label use because per the indications for use, "a strict anticoagulation protocol should be followed, and anticoagulation should be routinely monitored during all procedures.The prescribing physician must weigh the benefits of extracorporeal support against the risk of systemic anticoagulation.Adequate heparinization should be maintained per institution cardiopulmonary bypass (cpb) protocol." if the pump is run with insufficient fluid, for example in the presence of thrombus formation, this will cause degradation of the bearing, which would result in the grinding sound and failing reported.Saline or blood is required during use to cool the ceramic pump bearing.The ifu states, "formation of thrombus in the circuit may increase the risk of damage to the perfusion system equipment." there were no patient adverse effects.Trends for issues with this device are monitored.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: AFFINITY CP CENTRIFUGAL BLOOD PUMP
• Type of Device: TUBING, PUMP, 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12959261
• MDR Text Key: 284522494
• Report Number: 2184009-2021-00114
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K191077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2022
• Device Model Number: AP40
• Device Catalogue Number: AP40
• Device Lot Number: 219968111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Date Device Manufactured: 04/29/2020
• 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: 21 YR
• Patient Sex: Male
• Patient Weight: 140 KG