MAUDE Adverse Event Report: QUEST MEDICAL, INC. QUEST MPS DISPOSABLE; 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 06/27/2023

Event Type  malfunction  

Event Description

Quest mps disposable sn# (b)(6) has a pin hole leak in the blood pouch.Disposable will be sent back to quest for inspection.

• Brand Name: QUEST MPS DISPOSABLE
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): QUEST MEDICAL, INC.
• MDR Report Key: 17298864
• MDR Text Key: 318929400
• Report Number: MW5119260
• 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: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female