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

Model Number 5163102

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/09/2024

Event Type  Injury  

Manufacturer Narrative

No patient complications were reported.No complaint sample has been received for investigation.Quest medical has completed investigation through interviews and analysis of device history records.Quest will continue to monitor complaint trends.

Event Description

It was reported to quest medical that during a bypass procedure, patient may have experienced prolonged surgery due to an alleged leak from an mps 3 delivery set.There was a 5 minute delay in delivering cardiopleagia, but the procedure was completed with a new console and disposable.No patient complications reported.

• Brand Name: MPS 3 MYOCARDIAL PROTECTION SYSTEM (MPS 3) DELIVERY SET
• 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: 18615912
• MDR Text Key: 334223163
• Report Number: 1649914-2024-00001
• Device Sequence Number: 1
• Product Code: DTR
• UDI-Device Identifier: 00634624516311
• UDI-Public: 00634624516311
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200438
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5163102
• Device Lot Number: 70860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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
• Patient Outcome(s): Other