MAUDE Adverse Event Report: SORIN CUSTOM TUBING PACK; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Model Number CSC14

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Type  malfunction  

Event Description

"medtronic received information that prior to use of a custom tubing pack, the customer noted a tiny white particulate was found inside the recirculating prime.They clamped it out.There was no patient involvement so no adverse effect occurred." (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CUSTOM TUBING PACK
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN
• MDR Report Key: 17533000
• MDR Text Key: 321200140
• Report Number: MW5139906
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: CSC14
• Patient Sequence Number: 1