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

Model Number	5163102
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 1649914-2024-00001
• Device Sequence Number: 19449523
• Product Code: DTR
• UDI-Device Identifier: 00634624516311
• UDI-Public: 00634624516311
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K200438
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 5163102
• Device Lot Number: 70860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown