MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 2 DELIVERY SET; CPBP HEAT EXCHANGER

Model Number 5001102

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

Quest received the suspect device on 4/4/2023.The sample was tested to determine if there was any leaking from the water or blood side of the heat exchanger.No leaks were found.The complaint condition could not be reproduced.Quest has concluded its investigation.Quest will continue to monitor trends for this complaint condition.

Event Description

It was reported to quest medical by (b)(6) hospital, stating that there was an alleged potential water to blood leak in the heat exchanger.This was noted after cross-clamp removal.It was confirmed that there were no patient complications.

• Brand Name: MPS 2 DELIVERY SET
• Type of Device: CPBP HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer Contact: brian hedden ; 1 allentown parkway; allen, TX 75002 ; 9723326311
• MDR Report Key: 16820261
• MDR Text Key: 314082719
• Report Number: 1649914-2023-00016
• Device Sequence Number: 1
• Product Code: DTR
• UDI-Device Identifier: 00634624501126
• UDI-Public: 00634624501126
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/26/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 5001102
• Device Catalogue Number: 5001102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2023
• Initial Date FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1