MAUDE Adverse Event Report: PERFUSION SYSTEMS CARMEDA AFFINITY PEDIATRIC ARTERIAL BLOOD FILTER; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number S4014

Device Problem Insufficient Information (3190)

Patient Problems Seizures (2063); Brain Injury (2219); Low Oxygen Saturation (2477)

Event Date 03/20/2018

Event Type  Injury  

Manufacturer Narrative

Event date; month and year valid only.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via a solicitor that a patient is alleged to have suffered oxygen deprivation, seizures, hypoxic ischemic injury and brain damage.A list of devices which included a medtronic arterial filter, blood pump, tubing and cannulae as well as heart lung machine, oxygenator, autotransfusion device and reservoirs from non-medtronic companies.Information was provided that there were flow issues due to clotting and the arterial filter was bypassed.A new circuit was primed and put on standby but was not used.There has not been any communication from the hospital of any malfunction to a medtronic device.

Manufacturer Narrative

Investigation conclusion: complaint not confirmed for clotting during use of the pixie arterial filter and observed adverse patient effects.Review of the device history record found no abnormalities or ncmrs initiated during manufacturing that would cause or contribute to the reported event.Clinical review determined that the reported flow and clotting issues were likely related to a patient and/or clinical situation, rather than a malfunction of the medtronic device.Flow issues were noted during bypass initiation, and the arterial filter was bypassed due to clotting.After bypass, clotting was noted throughout the circuit and in the oxygenator.The reported clotting observed on the arterial filter provides evidence that the filter was functioning per the instructions for use (ifu) as the arterial filter is intended to remove particulate and gaseous microemboli from the circuit.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.

Event Description

Medtronic received information via a lawyer that a patient is alleged to have suffered oxygen deprivation, seizures, hypoxic ischemic injury and brain damage.A list of devices which included a medtronic arterial filter, blood pump, tubing and cannulae as well as heart lung machine, oxygenator, autotransfusion device and reservoirs from non-medtronic companies.Information was provided that there were flow issues due to clotting and the arterial filter was bypassed.A new circuit was primed and put on standby but was not used.There has not been any communication from the hospital of any malfunction to a medtronic device.

• Brand Name: CARMEDA AFFINITY PEDIATRIC ARTERIAL BLOOD FILTER
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 8509373
• MDR Text Key: 141771916
• Report Number: 2184009-2019-00014
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K071253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: S4014
• Device Catalogue Number: S4014
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 03/15/2019
• Supplement Dates FDA Received: 07/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 4 DA
• Patient Weight: 4