MAUDE Adverse Event Report: QUEST MEDICAL, INC MYOCARDIAL PROTECTION SYSTEM 2 DELIVERY SET; MPS 2 DELIVERY SET

Model Number	5001102-AS
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, quest is still pending completion of the investigation.A supplemental report will be filed at the completion of the investigation.
Event or Problem Description
It was reported to (b)(6) by university hospital ((b)(6)) that, after priming of the mps disposable set, the fluid level in the reservoir was noticeably higher and the water level in the heater/cooler was lower than at start of priming, indicating a leak.The disposable was removed and replaced prior to running the case.

• Brand Name: MYOCARDIAL PROTECTION SYSTEM 2 DELIVERY SET
• Common Device Name: MPS 2 DELIVERY SET
• Manufacturer (Section D): QUEST MEDICAL, INC; 1 allentown parkway; allen TX 75002
• MDR Report Key: 12103753
• Report Number: 1649914-2021-00006
• Device Sequence Number: 3713840
• Product Code: DTR
• UDI-Device Identifier: 00634624521124
• UDI-Public: 00634624521124
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K953838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2024
• Device Model Number: 5001102-AS
• Device Lot Number: 0620951A05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 07/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1