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

Model Number M470265D

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/13/2024

Event Type  malfunction  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information that prior to use of a custom tubing pack, the customer observed that during priming there was a leakage of the 3 way crane.The priming fluid was running out through the red hole in the middle.The device was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that there was no visible air in the system/tubing.

Manufacturer Narrative

Device evaluation summary: visual inspection shows evidence of a hole in the center on the knob.The customer provided a video showing evidence of the leak.The device was connected to a syringe filled with di water and a pressure gage.The syringe was engaged to apply approximately 25 psi and there was a leak observed from the center of the knob.Reason for return was confirmed.Unit will be held in (b)(6).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: CUSTOM TUBING PACK
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIAC SURGERY MFG KERKRADE; valkenhuizerlaan 16a; kerkrade 6466 ND; NL 6466 ND
• Manufacturer (Section G): CARDIAC SURGERY MFG KERKRADE; valkenhuizerlaan 16a; kerkrade 6466 ND; NL 6466 ND
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19059483
• MDR Text Key: 339591645
• Report Number: 6000033-2024-00008
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K171979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M470265D
• Device Catalogue Number: M470265D
• Device Lot Number: 227922402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/27/2023
• 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