MAUDE Adverse Event Report: CARDIAC SURGERY MFG KERKRADE TUBING PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number M443864C

Device Problem Disconnection (1171)

Patient Problem Blood Loss (2597)

Event Date 02/11/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Medtronic received information that during use, the customer reported the red pigtails tubing component from the perfusion pack was being used on an arterial oxygenator port.The customer was taking a sample from the pigtail tubing and had been checking the connection was tight.On gently bending the tubing, the tubing disconnected from the luer connector connected to the oxygenator.As the patient was flowing at approximately 4 liters per minute, approximately 100mls of blood escaped from the luer connector before the customer could resolve the issue (quickly turned off flows for a brief few seconds - to replace the pigtail).The patient did require 1 unit of red blood cells, but the customer stated that as the patient was already bleeding that they could not confirm the 100ml blood loss added to that clinical decision.The product was used to complete the case.

Manufacturer Narrative

Visual analysis: visual inspection shows the luer fitting is separated from the tubing.The specification provided by the customer indicates that the connection is dry bonded with the d next to the connection.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.

Manufacturer Narrative

Conclusion: those connections passed the same tests (pull and leak tests) than connections with solvents.Most probably the operator did not make a correct dry connection during the assembly between the 3/16 luer connector and the tubing.Performed device history check, no anomalies detected.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: TUBING PACK
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIAC SURGERY MFG KERKRADE; valkenhuizerlaan 16a; kerkrade 6466 ND; NL 6466 ND
• MDR Report Key: 9768817
• MDR Text Key: 188816627
• Report Number: 6000033-2020-00003
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K800178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 04/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: M443864C
• Device Catalogue Number: M443864C
• Device Lot Number: 217448105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Initial Date Manufacturer Received: 02/12/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 03/10/2020; 04/15/2020
• Supplement Dates FDA Received: 04/06/2020; 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention