MAUDE Adverse Event Report: MEDTRONIC MEXICO CUSTOM TUBING PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number CC11H90R3

Device Problem Obstruction of Flow (2423)

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

Event Date 02/29/2024

Event Type  malfunction  

Event Description

Medtronic received information that prior to use of a custom tubing pack, the customer reported that during the suction test, the one-way valve in the suction circuit did not function and it could not be used.The customer stated that the valve was connected in a normal direction. as the problem was discovered just before the start of surgery, there was no time to replace the circuit and no single one-way valve was available, therefore, the surgery had to be performed without this one-way valve.The remainder of the custom tubing pack was used.There was no adverse patient effects.Medtronic received additional information that the device was unusable during the priming check.

Manufacturer Narrative

Device evaluation summary: upon receipt in our quality analysis lab, visual inspection shows the positive umbrella valve is missing.The valve has the test mark, which confirmed the vrv was tested prior to distribution.Functional testing was performed at 0.5 l/min.With the positive umbrella valves missing they did not draw the fluid from the water source due to the air leak from the missing umbrella valve.When the umbrella valve hole was covered the valve operated as expected.When the pump was stopped the device leaked water through the hole from the missing umbrella valve.Reason for return was confirmed.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): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18992786
• MDR Text Key: 338986182
• Report Number: 9612164-2024-01501
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CC11H90R3
• Device Catalogue Number: CC11H90R3
• Device Lot Number: 227219443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2023
• 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