MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 3 ND CONSOLE; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Lot Number 5301000ND

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

Event Date 08/14/2023

Event Type  Injury  

Event Description

During a cabg surgery mps 3nd stopped giving cardioplegia despite multiple previous successful doses.Surgeon decided to remove cross clamp and finish the last remaining anastomosis by utilizing the octopus evolution stabilizer via pump assist.Patient came off bypass smoothly and without adverse event.Multiple inadequate inlet fill alarms as well as unable to maintain flowrate alarms (error codes 65-2082, 190-2093, 65-2083, 190-2093, 190-2093, 65-2083).They checked for kinks in the inlet line but everything appeared normal.Unit sent back to company for evaluation & repair.

• Brand Name: MPS 3 ND CONSOLE
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): QUEST MEDICAL, INC.
• MDR Report Key: 17586072
• MDR Text Key: 321743251
• Report Number: MW5144788
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 5301000ND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White