MAUDE Adverse Event Report: QUEST MEDICAL, INC. QUEST 67714; HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 03/13/2023

Event Type  Other  

Event Description

Mps 3 disposable leaking.Pin size hole in the sterile tubing.Reported to manufacturer.No harm to patient.

• Brand Name: QUEST 67714
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): QUEST MEDICAL, INC.
• MDR Report Key: 16701636
• MDR Text Key: 313007000
• Report Number: MW5116453
• 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: 04/04/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2023
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male