MAUDE Adverse Event Report: CARDIAC SURGERY MFG KERKRADE PERFUSION PACK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number M332710K

Device Problem Fluid/Blood Leak (1250)

Patient Problems Death (1802); Neurological Deficit/Dysfunction (1982)

Event Date 10/21/2019

Event Type  Death  

Manufacturer Narrative

Perfusion pack cannot be evaluated as it was discarded by the customer.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of a perfusion tubing pack and fusion oxygenator the customer observed clotting around the surface of the oxygenator at the start of bypass.A blood leak was observed at the venous line entrance to the oxygenator towards the end of bypass, approximately 1.5 hrs into the procedure.The products were replaced to complete the case.The patient had a neurological complication (thrombotic stroke) following the procedure in the recovery unit.The patient expired two days after surgery.

Event Description

Medtronic received information that during use of a perfusion tubing pack and fusion oxygenator the customer observed clotting around the surface of the oxygenator at the start of bypass.A blood leak was observed at the venous line entrance to the oxygenator towards the end of bypass, approximately 1.5hrs into the procedure.The products were replaced to complete the case.The patient had a neurological complication (thrombotic stroke) following the procedure in the recovery unit.The patient expired two days after surgery.

Manufacturer Narrative

Medtronic investigation: complaint is unconfirmed for clotting in the tubing pack as the only product returned for analysis was the fusion oxygenator, which was part of the tubing pack.There was no observed damage to the oxygenator and performance testing indicated that the device functioned as intended.Dhr was reviewed and no anomalies were found during the manufacturing of the tubing pack.Complaints received for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.A capa will not be initiated at this time.Medtronic will continue to monitor for future occurrences and trends.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: PERFUSION PACK
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIAC SURGERY MFG KERKRADE; valkenhuizerlaan 16a; kerkrade 6466 ND; NL 6466 ND
• MDR Report Key: 9267310
• MDR Text Key: 165639259
• Report Number: 6000033-2019-00003
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K924529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: M332710K
• Device Catalogue Number: M332710K
• Device Lot Number: 217755702
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2019
• Initial Date FDA Received: 11/01/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 51 YR
• Patient Weight: 83