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

Model Number	5301000ND
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quest has received the suspect device, but has not completed its investigation.A supplemental report will be filed at the conclusion of this investigation.
Event or Problem Description
It was reported to quest that during a case, while delivering cardioplegia, the amount notification alerted the user that there was 10ml of arrest agent left in the cartridge.After the perfusionist pressed the refill button and pushed the drug into the cartridge, the button failed to appear allowing the user to continue the operation.The console had to be power cycled and re-primed in order to reactivate the arrest drug piston.After power cycling, the device functioned normally.
Event or Problem Description
It was reported to quest that during a case, while delivering cardioplegia, the amount notification alerted the user that there was 10ml of arrest agent left in the cartridge.After the perfusionist pressed the refill button and pushed the drug into the cartridge, the button failed to appear allowing the user to continue the operation.The console had to be power cycled and re-primed in order to reactivate the arrest drug piston.After power cycling, the device functioned normally.
Additional Manufacturer Narrative
Quest could not duplicate the reported complaint condition.It will continue to monitor complaint trends for this product.Quest has concluded the investigation of this unit.

• Brand Name: MYOCARDIAL PROTECTION SYSTEM 3 ND
• Common Device Name: MPS 3 ND
• Manufacturer (Section D): QUEST MEDICAL, INC.; 1 allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC; 1 allentown parkway; allen TX 75002
• Manufacturer Contact: brian hedden ; 1 allentown parkway; allen, TX 75002
• MDR Report Key: 12365296
• Report Number: 1649914-2021-00007
• Device Sequence Number: 4536530
• Product Code: DTR
• UDI-Device Identifier: 20634624531004
• UDI-Public: 20634624531004
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K201984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2021

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 Model Number: 5301000ND
• Device Catalogue Number: 5301000ND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/30/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female