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

Model Number 5001102-AS

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/04/2021

Event Type  malfunction  

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 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
• Type of Device: MPS 2 DELIVERY SET
• Manufacturer (Section D): QUEST MEDICAL, INC; 1 allentown parkway; allen TX 75002
• Manufacturer Contact: brian hedden ; 1 allentown parkway; allen, TX 75002 ; 9723326311
• MDR Report Key: 12103753
• MDR Text Key: 259703665
• Report Number: 1649914-2021-00006
• Device Sequence Number: 1
• Product Code: DTR
• UDI-Device Identifier: 00634624521124
• UDI-Public: 00634624521124
• 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: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2021
• 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