MAUDE Adverse Event Report: PERFUSION SYSTEMS OXY/CVR COMBO BB841 FUSION W/BALANCE 26L; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BB841

Device Problems Increase in Pressure (1491); Air/Gas in Device (4062)

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

Event Date 01/29/2024

Event Type  malfunction  

Event Description

Medtronic received information that during use of a fusion cardiotomy venous reservoir, the customer reported that the reservoirs would not hold the full vacuum pressure.The customer observed that the reservoirs would not hold full vacuum pressure.The customer stated that this indicated that there was air escaping from the circuit (a leak) and when there was slight downward pressure put on the neck of the pump suckers connection, the reservoirs would sometimes temporarily seal and return to full vacuum with no air escaping.The customer believed that the seal on the circular part that connects to the suckers was insufficient.The use of the device was unspecified.There was no adverse patient effect associated with this event.

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.

Manufacturer Narrative

Correction b3: exact date of event is unknown, year valid only.Correction b5: note: the customer stated that this issue had happened 6 to 8 times, however the exact event details and number of occurrences is unknown.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: OXY/CVR COMBO BB841 FUSION W/BALANCE 26L
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18986706
• MDR Text Key: 338759254
• Report Number: 2184009-2024-00135
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K230640
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

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 Model Number: BB841
• Device Catalogue Number: BB841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 04/30/2024
• Supplement Dates FDA Received: 04/30/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1