MAUDE Adverse Event Report: QUEST MEDICAL, INC. MPS 3 ND MYOCARDIAL PROTECTION SYSTEM; CARDIOPULMONARY BYPASS HEAT EXCHANGER

Model Number 5301000ND

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/26/2024

Event Type  Injury  

Manufacturer Narrative

No patient complications were reported.No complaint sample has been received for investigation, however, quest medical retrieved data logs from the device and analyzed the information.Quest medical has also completed investigation through interviews and analysis of device history records.Although no device problem was found, quest will continue to monitor complaint trends.

Event Description

It was reported that during cardioplegia delivery, an error message occurred that required the restart of the device that may have led to a delay in procedure.The cross clamp was removed and replaced, and the procedure was completed with no patient complications.

• Brand Name: MPS 3 ND MYOCARDIAL PROTECTION SYSTEM
• Type of Device: CARDIOPULMONARY BYPASS HEAT EXCHANGER
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002 4211
• Manufacturer (Section G): QUEST MEDICAL, INC; one allentown parkway; allen TX 75002 4211
• Manufacturer Contact: stephanie ajayi ; one allentown parkway; allen, TX 75002-4211 ; 9723326290
• MDR Report Key: 19106078
• MDR Text Key: 340160969
• Report Number: 1649914-2024-00002
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201984
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5301000ND
• Device Lot Number: 4189
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention